Olympus Corporation of the Americas

Date	Severity	Status	Recall #	Product	Code	Reason
2026-08-19	Class II	Ongoing	Z-3247-2026	Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.	—	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Class II	Ongoing	Z-3246-2026	Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.	—	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Class II	Ongoing	Z-3245-2026	Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.	—	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Class II	Ongoing	Z-3244-2026	Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.	—	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Class II	Ongoing	Z-3216-2026	Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.	—	Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
2026-08-18	Class II	Ongoing	Z-3035-2026	POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting…	—	Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2026-07-07	Class II	Ongoing	Z-2761-2026	Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displayi…	—	Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
2026-06-16	Class II	Ongoing	Z-2776-2026	Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4	—	Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
2026-06-05	Class II	Ongoing	Z-2676-2026	Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designe…	—	Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
2026-03-25	Class II	Ongoing	Z-1909-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1908-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1907-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1906-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1905-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1904-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1903-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.	—	XXX
2026-03-25	Class II	Ongoing	Z-1902-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1901-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1900-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1899-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-25	Class II	Ongoing	Z-1898-2026	OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OE…	—	Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
2026-03-23	Class II	Ongoing	Z-1854-2026	Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.	—	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Class II	Ongoing	Z-1853-2026	Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.	—	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Class II	Ongoing	Z-1852-2026	Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.	—	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Class II	Ongoing	Z-1851-2026	Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.	—	Potential for detachment of a distal tip component of the device during use.
2026-02-27	Class II	Ongoing	Z-1695-2026	Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog …	—	Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system…
2026-02-27	Class II	Ongoing	Z-1694-2026	Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/…	—	Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system…
2026-02-25	Class II	Ongoing	Z-1644-2026	Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Pr…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-25	Class II	Ongoing	Z-1643-2026	Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 92000…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-25	Class II	Ongoing	Z-1642-2026	Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Prod…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-25	Class II	Ongoing	Z-1641-2026	Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HA…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-25	Class II	Ongoing	Z-1640-2026	Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Pro…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-25	Class II	Ongoing	Z-1639-2026	Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Mo…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-25	Class II	Ongoing	Z-1638-2026	Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca…	—	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can resul…
2026-02-12	Class II	Ongoing	Z-1613-2026	Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.	—	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
2026-02-12	Class II	Ongoing	Z-1612-2026	Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.	—	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
2026-02-12	Class II	Ongoing	Z-1611-2026	Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.	—	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
2026-02-12	Class II	Ongoing	Z-1610-2026	Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.	—	The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
2026-01-29	Class II	Ongoing	Z-1489-2026	Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to …	—	Potential for rubber fragment detachment during use.
2026-01-29	Class II	Ongoing	Z-1488-2026	Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be…	—	Potential for rubber fragment detachment during use.
2026-01-16	Class I	Ongoing	Z-1354-2026	Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat…	—	Issue with software algorithm which may lead to overpressure events.
2026-01-16	Class I	Ongoing	Z-1353-2026	Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa…	—	Issue with software algorithm which may lead to overpressure events.
2026-01-16	Class I	Ongoing	Z-1352-2026	Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic…	—	Issue with software algorithm which may lead to overpressure events.
2026-01-08	Class II	Ongoing	Z-1494-2026	Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re…	—	Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consi…
2026-01-07	Class II	Ongoing	Z-1297-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1296-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instr…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1295-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instr…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1294-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1293-2026	Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1292-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instr…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1291-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instr…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1290-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instr…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1289-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1288-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1287-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1286-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1285-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1284-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1283-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1282-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1281-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1280-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1279-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1278-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software …	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1277-2026	Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1276-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1275-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1274-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1273-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1272-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1271-2026	Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1270-2026	Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1269-2026	Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio…	—	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Class II	Ongoing	Z-1268-2026	Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software…	—	Devices which did not undergo thermoforming could deform and lose performance.
2025-11-14	Class II	Ongoing	Z-1479-2026	Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog …	—	Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the …
2025-11-14	Class II	Ongoing	Z-1478-2026	Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes …	—	Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the …
2025-11-14	Class II	Ongoing	Z-1477-2026	Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes M…	—	Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the …
2025-11-11	Class II	Ongoing	Z-1457-2026	Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1456-2026	Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1455-2026	Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1454-2026	Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1453-2026	Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1452-2026	Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1451-2026	Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1450-2026	Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1449-2026	Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1448-2026	Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1447-2026	Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1446-2026	Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio…	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1445-2026	Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1444-2026	Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application…	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1443-2026	Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1442-2026	Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio…	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1441-2026	Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1440-2026	Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1439-2026	Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11	Class II	Ongoing	Z-1438-2026	Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applicatio…	—	Complaints of the ceramic tip of the resection sheath breaking have been received.
2025-10-30	Class I	Ongoing	Z-0570-2026	Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…	—	Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy…
2025-10-22	Class II	Ongoing	Z-1382-2026	Olympus Thunderbeat 5 mm, 10 cm, Inline Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1381-2026	Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1380-2026	Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1379-2026	Olympus Thunderbeat, 5 mm, 45 cm Inline Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1378-2026	Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1377-2026	Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1376-2026	Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1375-2026	Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1374-2026	Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1373-2026	Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1372-2026	Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-22	Class II	Ongoing	Z-1371-2026	Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S	—	Firm is initiating a removal due to continued reports of adverse events.
2025-10-17	Class II	Ongoing	Z-0572-2026	Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro…	—	Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon cathe…
2025-10-14	Class II	Ongoing	Z-0579-2026	Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product …	—	Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope…
2025-10-08	Class II	Ongoing	Z-0452-2026	Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod…	—	The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body…
2025-10-06	Class II	Ongoing	Z-0483-2026	Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi…	—	Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf car…
2025-10-06	Class II	Ongoing	Z-0482-2026	Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal…	—	Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf car…
2025-09-11	Class I	Ongoing	Z-0067-2026	OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0066-2026	EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0065-2026	EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0064-2026	BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0063-2026	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0062-2026	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0061-2026	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0060-2026	BRONCHOVIDEOSCOPE OLYMPUS BF-Q170	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0059-2026	BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0058-2026	OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0057-2026	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0056-2026	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0055-2026	BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0054-2026	OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0053-2026	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0052-2026	BRONCHOVIDEOSCOPE OLYMPUS BF-H1100	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0051-2026	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0050-2026	BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0049-2026	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0048-2026	BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0047-2026	OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0046-2026	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-09-11	Class I	Ongoing	Z-0045-2026	BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150	—	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation…
2025-08-06	Class I	Ongoing	Z-2484-2025	ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device …	—	Potential for undetected, deformed a-traumatic tips.
2025-07-25	Class II	Ongoing	Z-2339-2025	Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. …	—	Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device…
2025-07-25	Class II	Ongoing	Z-2338-2025	Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SE…	—	Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device…
2025-06-18	Class II	Ongoing	Z-2146-2025	Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessor…	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2145-2025	Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible …	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2144-2025	Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible w…	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2143-2025	Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite …	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2142-2025	Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are …	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2141-2025	Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible w…	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2140-2025	Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone se…	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-06-18	Class II	Ongoing	Z-2139-2025	Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the b…	—	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions F…
2025-05-06	Class II	Ongoing	Z-1923-2025	Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FB…	—	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber…
2025-05-06	Class II	Ongoing	Z-1922-2025	Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalo…	—	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber…
2025-05-06	Class II	Ongoing	Z-1921-2025	Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Num…	—	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber…
2025-05-06	Class II	Ongoing	Z-1920-2025	Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number:…	—	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber…
2025-05-05	Class II	Ongoing	Z-1911-2025	Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V	—	Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was de…
2025-04-04	Class II	Ongoing	Z-1715-2025	Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers…	—	Preset treatment parameters are not consistently being used in accordance with the IFU.
2025-01-15	Class I	Ongoing	Z-1071-2025	Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide S…	—	Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
2024-12-18	Class I	Ongoing	Z-0905-2025	Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design…	—	Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembli…
2024-12-16	Class II	Ongoing	Z-0962-2025	LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V u…	—	Potential for distal tip tearing of the Mechanical Lithotriptor V.
2024-11-25	Class II	Ongoing	Z-1003-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-1002-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-1001-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-1000-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0999-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0998-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0997-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0996-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0995-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0994-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-25	Class II	Ongoing	Z-0993-2025	Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front…	—	The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
2024-11-19	Class II	Ongoing	Z-0707-2025	Duravent Silicone Ventilation Tube. Model Number: 240075.	—	Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended D…
2024-10-31	Class II	Ongoing	Z-0620-2025	EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190	—	High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible repr…
2024-09-24	Class II	Ongoing	Z-0232-2025	Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is…	—	Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedur…
2024-09-18	Class II	Ongoing	Z-0498-2025	Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Numbe…	—	To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and conc…
2024-09-13	Class II	Ongoing	Z-1437-2026	Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;	—	Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
2024-09-13	Class II	Ongoing	Z-0351-2025	Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Produ…	—	Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged…
2024-09-13	Class II	Ongoing	Z-0225-2025	EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat…	—	Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surge…
2024-09-11	Class II	Ongoing	Z-0364-2025	Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038…	—	Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the pa…
2024-09-04	Class II	Ongoing	Z-0264-2025	Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U	—	There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
2024-08-23	Class II	Ongoing	Z-0229-2025	Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)	—	During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
2024-08-21	Class II	Ongoing	Z-0181-2025	Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100	—	It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifi…
2024-08-13	Class II	Ongoing	Z-0135-2025	Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and…	—	The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a…
2024-08-13	Class II	Ongoing	Z-0134-2025	Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v…	—	The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a…
2024-07-01	Class II	Ongoing	Z-2542-2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou…	—	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
2024-07-01	Class II	Ongoing	Z-2541-2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou…	—	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
2024-07-01	Class II	Ongoing	Z-2540-2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou…	—	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
2024-06-21	Class II	Ongoing	Z-2415-2024	ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation …	—	Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
2024-05-31	Class II	Ongoing	Z-2506-2024	Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL	—	Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
2024-05-31	Class II	Ongoing	Z-2505-2024	Soltive Pro SuperPulsed Laser System, Model TFL-SLS	—	Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
2024-05-31	Class II	Ongoing	Z-2504-2024	Soltive Premium SuperPulsed Laser System, Model TFL-PLS	—	Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
2024-04-24	Class II	Ongoing	Z-2233-2024	EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a to…	—	A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that…
2024-04-18	Class II	Ongoing	Z-2029-2024	OES 4000 Hysteroscope, Model/Catalog Number: A4674A	—	The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and c…
2024-04-03	Class II	Ongoing	Z-1888-2024	InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid en…	—	Potential for distal end of the sheath to break off during a procedure.
2024-03-07	Class II	Ongoing	Z-1701-2024	POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur…	—	Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on …
2024-03-07	Class II	Ongoing	Z-1700-2024	POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur…	—	Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on …
2024-03-07	Class II	Ongoing	Z-1699-2024	POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such sur…	—	Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on …
2024-03-01	Class II	Ongoing	Z-1548-2024	Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue …	—	Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the…
2024-03-01	Class II	Ongoing	Z-1547-2024	Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue …	—	Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the…
2024-02-17	Class II	Ongoing	Z-1223-2026	Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode…	—	A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
2024-02-17	Class II	Ongoing	Z-1222-2026	Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata…	—	A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
2024-01-29	Class II	Ongoing	Z-1385-2024	SOLTIVE Premium SuperPulsed Laser (TFL-PLS )	—	A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
2024-01-29	Class II	Ongoing	Z-1384-2024	SOLTIVE Pro SuperPulsed Laser (TFL-SLS )	—	A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
2024-01-16	Class II	Ongoing	Z-1368-2024	InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Mod…	—	Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order t…
2024-01-16	Class II	Ongoing	Z-1009-2024	Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for pr…	—	Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially cont…
2024-01-11	Class II	Ongoing	Z-1214-2024	Colonoscope, Model Number PCF-Q180AL.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1213-2024	Colonoscope, Model Number PCF-HQ190L.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1212-2024	Colonoscope, Model Number PCF-H190TL.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1211-2024	Colonoscope, Model Number PCF-H190L.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1210-2024	Colonoscope, Model Number PCF-H190DL.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1209-2024	Colonoscope, Model Number PCF-H180AL.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1208-2024	Colonoscope, Model Number CF-Q180AL.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1207-2024	Colonoscope, Model Number CF-HQ190L.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1206-2024	Colonoscope, Model Number CF-HQ190I.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-11	Class II	Ongoing	Z-1205-2024	Colonoscope, Model Number CF-H180AL.	—	Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl…
2024-01-05	Class II	Ongoing	Z-1481-2024	Hemostasis Probe, Model: CD-B622LA	—	The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
2023-12-15	Class II	Ongoing	Z-1167-2024	ESG PK CUTTING FORCEPS, 5MM, 33CM	—	The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
2023-12-11	Class II	Ongoing	Z-1004-2024	Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media…	—	The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, fo…
2023-12-08	Class II	Ongoing	Z-1071-2024	Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olym…	—	Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, pe…
2023-12-04	Class II	Ongoing	Z-0718-2024	SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS	—	Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use)…
2023-12-04	Class II	Ongoing	Z-0717-2024	Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC	—	The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructio…
2023-12-04	Class II	Ongoing	Z-0716-2024	Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-A…	—	The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructio…
2023-12-01	Class II	Ongoing	Z-0748-2024	SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX…	—	Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the cur…
2023-11-20	Class II	Ongoing	Z-0645-2024	OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, lig…	—	Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for…
2023-11-20	Class II	Ongoing	Z-0644-2024	OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, l…	—	Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for…
2023-11-10	Class II	Ongoing	Z-0944-2024	EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adul…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0943-2024	EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adult…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0942-2024	EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0941-2024	EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adult…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0940-2024	EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in a…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0939-2024	EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0938-2024	EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0937-2024	EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0936-2024	EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults a…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0935-2024	EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and ado…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0934-2024	EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-10	Class II	Ongoing	Z-0933-2024	EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoles…	—	Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and pro…
2023-11-06	Class II	Ongoing	Z-0697-2024	Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light sou…	—	Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surger…
2023-10-12	Class I	Ongoing	Z-0194-2024	EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190	—	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosur…
2023-10-12	Class I	Ongoing	Z-0193-2024	EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190	—	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosur…
2023-10-12	Class I	Ongoing	Z-0192-2024	EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model…	—	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosur…
2023-10-12	Class I	Ongoing	Z-0191-2024	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180	—	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosur…
2023-10-12	Class I	Ongoing	Z-0190-2024	EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC	—	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosur…
2023-10-12	Class I	Ongoing	Z-0189-2024	BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM…	—	There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosur…
2023-10-02	Class II	Ongoing	Z-0568-2024	ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo…	—	Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
2023-10-02	Class II	Ongoing	Z-0288-2024	EVIS EXERA III Gastrointestinal Videoscope	—	Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
2023-09-28	Class II	Ongoing	Z-0557-2024	TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP	—	Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
2023-09-25	Class II	Ongoing	Z-1375-2024	Insufflation unit, UHI-4.	—	Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning o…
2023-09-22	Class I	Ongoing	Z-0075-2024	Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.	—	There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events m…
2023-09-14	Class II	Ongoing	Z-0056-2025	EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light…	—	Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
2023-09-12	Class II	Ongoing	Z-0109-2024	THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including singl…	—	Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in pro…
2023-09-12	Class II	Ongoing	Z-0108-2024	THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including sing…	—	Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in pro…
2023-08-10	Class II	Ongoing	Z-2664-2023	Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19…	—	Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation ins…
2023-08-10	Class II	Ongoing	Z-2663-2023	Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Alw…	—	Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation ins…
2023-08-10	Class II	Ongoing	Z-2662-2023	Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440…	—	Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation ins…
2023-08-10	Class II	Ongoing	Z-2661-2023	Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-56…	—	Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation ins…
2023-08-10	Class II	Ongoing	Z-2660-2023	Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Ac…	—	Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation ins…
2023-08-10	Class II	Ongoing	Z-2659-2023	Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN…	—	Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation ins…
2023-07-27	Class II	Ongoing	Z-2504-2023	Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2503-2023	Olympus Bronchovideoscope, Models BF-3C160.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2502-2023	Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2501-2023	Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2500-2023	Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2499-2023	Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2498-2023	Olympus Bronchovideoscope, Models BF-XT190.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2497-2023	Olympus Bronchovideoscope, Models BF-MP190F.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2496-2023	Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2495-2023	Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2494-2023	Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2493-2023	Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2492-2023	Olympus Bronchovideoscope, Model BF-Q180-AC	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2491-2023	Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2490-2023	Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.	—	Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
2023-07-27	Class II	Ongoing	Z-2467-2023	EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V	—	Recent reports of patient infection.
2023-07-20	Class II	Ongoing	Z-2480-2023	Visera Hysterovideoscope Olympus HYF Type V	—	IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
2023-07-12	Class II	Ongoing	Z-2447-2023	The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO…	—	The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated end…
2023-06-08	Class II	Ongoing	Z-2413-2023	HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme…	—	Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact w…
2023-06-08	Class I	Ongoing	Z-2017-2023	Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-06-08	Class I	Ongoing	Z-2016-2023	Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-06-08	Class I	Ongoing	Z-2015-2023	Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-06-08	Class I	Ongoing	Z-2014-2023	Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-06-08	Class I	Ongoing	Z-2013-2023	Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-06-08	Class I	Ongoing	Z-2012-2023	Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-06-08	Class I	Ongoing	Z-2011-2023	Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60	—	There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
2023-05-26	Class II	Ongoing	Z-2344-2023	Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexib…	—	Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The ad…
2023-05-26	Class II	Ongoing	Z-2343-2023	Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl…	—	Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The ad…
2023-05-26	Class II	Ongoing	Z-2342-2023	Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible…	—	Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The ad…
2023-05-26	Class II	Ongoing	Z-2341-2023	Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m…	—	Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The ad…
2023-05-26	Class II	Ongoing	Z-2340-2023	VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to …	—	Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The ad…
2023-05-19	Class II	Ongoing	Z-2401-2023	UroPass Ureteral Access Sheaths, 5 pieces/box	—	Dilator tips may break in the package and in patients during surgical procedures.
2023-05-15	Class II	Ongoing	Z-2269-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical int…	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2268-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in c…	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2267-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in cli…	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2266-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use …	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2265-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use…	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2264-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical …	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2263-2023	Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical int…	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-15	Class II	Ongoing	Z-2262-2023	Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interv…	—	Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a …
2023-05-04	Class II	Ongoing	Z-1990-2023	Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu…	—	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo…
2023-05-04	Class II	Ongoing	Z-1989-2023	Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog …	—	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo…
2023-05-04	Class II	Ongoing	Z-1988-2023	Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu…	—	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo…
2023-05-04	Class II	Ongoing	Z-1987-2023	Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog …	—	Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deplo…
2023-04-18	Class II	Ongoing	Z-1613-2023	Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: C…	—	The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could inclu…
2023-03-31	Class III	Ongoing	Z-1616-2023	To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural le…	—	Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance exp…
2023-03-31	Class III	Ongoing	Z-1615-2023	ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle as…	—	Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance exp…
2023-02-23	Class II	Ongoing	Z-1418-2023	Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip …	—	There have been complaints that the clip did not come out of the tube sheath during the procedure.
2022-12-21	Class II	Ongoing	Z-1132-2023	EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anu…	—	A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in e…
2022-12-13	Class II	Ongoing	Z-1103-2023	SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)	—	A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect …
2022-11-04	Class II	Ongoing	Z-0424-2023	HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S	—	An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay…
2022-09-16	Class II	Ongoing	Z-0078-2023	Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.	—	Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reporte…
2022-08-12	Class II	Ongoing	Z-1815-2022	Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgi…	—	An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and ret…
2022-08-12	Class II	Ongoing	Z-1814-2022	Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgi…	—	An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and ret…
2022-08-12	Class II	Ongoing	Z-1813-2022	Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgi…	—	An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and ret…
2022-07-07	Class II	Ongoing	Z-1514-2022	ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S	—	Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consi…
2022-05-26	Class II	Terminated	Z-1296-2022	SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # …	—	Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
2022-04-22	Class II	Ongoing	Z-1275-2022	EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, s…	—	Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Ol…
2022-04-22	Class II	Terminated	Z-1274-2022	Colonovideoscope Model CF-H180AL	—	A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H18…
2022-04-20	Class II	Ongoing	Z-1264-2022	Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R	—	Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading t…
2022-04-20	Class II	Ongoing	Z-1263-2022	Olympus URETERO-RENO FIBERSCOPE Model: URF-P6	—	Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading t…
2022-04-20	Class II	Ongoing	Z-1262-2022	Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5	—	Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading t…
2022-03-31	Class II	Terminated	Z-1122-2022	Olympus DISPOSABLE GRASPING FORCEPS, FG-51D	—	Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
2022-03-25	Class II	Ongoing	Z-1116-2022	Olympus Uretero-reno videoscope, Model No. URF-V2	—	The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
2022-03-18	Class II	Ongoing	Z-1034-2022	Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.	—	GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
2022-03-08	Class II	Ongoing	Z-1049-2022	BF-1TQ180: EVIS EXERA II Bronchovideoscope	—	Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after hi…
2022-03-08	Class II	Ongoing	Z-1048-2022	BF-MP160F: EVIS EXERA Bronchofibervideoscope	—	Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after hi…
2022-03-08	Class II	Ongoing	Z-1047-2022	BF-3C160: EVIS EXERA Bronchovideoscope	—	Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after hi…
2022-03-08	Class II	Ongoing	Z-1046-2022	BF-MP60: OES Bronchofiberscope	—	Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after hi…
2021-12-23	Class II	Ongoing	Z-0551-2022	Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortn…	—	Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
2021-12-13	Class II	Terminated	Z-0638-2022	OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endos…	—	The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed i…
2021-11-02	Class II	Ongoing	Z-0379-2022	EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V	—	Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; co…
2021-09-21	Class II	Terminated	Z-0176-2022	ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple …	—	Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the b…
2021-08-17	Class II	Terminated	Z-2497-2021	EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160	—	A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak,…
2021-08-16	Class II	Terminated	Z-2573-2021	BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2572-2021	BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2571-2021	BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2570-2021	BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2569-2021	BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2568-2021	BF-P60 OES Bronchofiberscope, Model No. BF-P60	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2567-2021	BF-1T60 OES Bronchofiberscope, Model No. BF-1T60	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2566-2021	BF-XP60 OES Bronchofiberscope, Model No. BF-XP60	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2565-2021	BF-3C40 OES Bronchofiberscope, Model No. BF-3C40	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-16	Class II	Terminated	Z-2564-2021	BF-N20 OES Bronchofiberscope, Model No. BF-N20	—	The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validati…
2021-08-03	Class II	Terminated	Z-2423-2021	Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, P…	—	Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
2021-06-30	Class II	Terminated	Z-2294-2021	Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, ex…	—	Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
2021-06-09	Class II	Terminated	Z-2380-2021	Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue…	—	Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within …
2021-01-28	Class II	Terminated	Z-1292-2021	Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, do…	—	Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, …
2020-10-16	Class II	Terminated	Z-0507-2021	Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the …	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0506-2021	Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or flu…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0505-2021	Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or flu…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0504-2021	Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid fl…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0503-2021	Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0502-2021	Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center,…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0501-2021	Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0500-2021	Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultraso…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0499-2021	Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endo…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-10-16	Class II	Terminated	Z-0498-2021	Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for end…	—	A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin…
2020-08-31	Class II	Terminated	Z-3017-2020	Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial num…	—	The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections th…
2020-08-31	Class II	Terminated	Z-0119-2021	Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, li…	—	The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of meta…
2020-07-14	Class II	Terminated	Z-2814-2020	Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662	—	Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 701421…
2020-07-14	Class II	Terminated	Z-2813-2020	Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168	—	Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 701421…
2020-05-05	Class II	Terminated	Z-2292-2020	ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.	—	Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
2020-04-23	Class II	Terminated	Z-2197-2020	OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer	—	A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
2020-03-23	Class II	Terminated	Z-1763-2020	Olympus Pleuravideoscope, Model LTF-240	—	There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are bei…
2020-03-23	Class II	Terminated	Z-1762-2020	Olympus Pleuravideoscope, Model LTF-160	—	There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are bei…

Clearance cadence by quarter

Product codes worked

Recalls (362)

510(k) clearances (none indexed)