| 2026-05-08 |
Class II
|
Ongoing |
Z-2517-2026 |
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 … |
— |
Due to unsealed portions of pouches. |
| 2026-04-02 |
Class II
|
Ongoing |
Z-2004-2026 |
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY |
— |
catheter may experience resistance when being advanced over the guidewire |
| 2026-04-02 |
Class II
|
Ongoing |
Z-2003-2026 |
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY |
— |
catheter may experience resistance when being advanced over the guidewire |
| 2026-04-02 |
Class II
|
Ongoing |
Z-2002-2026 |
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY |
— |
catheter may experience resistance when being advanced over the guidewire |
| 2026-02-13 |
Class I
|
Ongoing |
Z-1579-2026 |
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96… |
— |
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,… |
| 2026-02-13 |
Class I
|
Ongoing |
Z-1578-2026 |
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030… |
— |
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,… |
| 2026-02-13 |
Class I
|
Ongoing |
Z-1577-2026 |
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B |
— |
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,… |
| 2026-02-13 |
Class I
|
Ongoing |
Z-1576-2026 |
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, … |
— |
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,… |
| 2026-02-13 |
Class I
|
Ongoing |
Z-1575-2026 |
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K… |
— |
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,… |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1129-2026 |
Allwell Angioplasty Pack REF: IS-30-B1/B |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1128-2026 |
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1127-2026 |
Merit Medical , Custom Manifold Kit REF: K09-13203A |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1126-2026 |
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05… |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1125-2026 |
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1124-2026 |
Allwell Inflation Device, for angiographic use REF: IS-30-A |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 |
Class II
|
Ongoing |
Z-1123-2026 |
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130… |
— |
Inflation device handle may detach from the syringe during procedure. |
| 2025-08-04 |
Class II
|
Ongoing |
Z-0533-2026 |
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, … |
— |
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconv… |
| 2025-07-25 |
Class II
|
Ongoing |
Z-2553-2025 |
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /… |
— |
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. |
| 2025-06-05 |
Class II
|
Ongoing |
Z-2296-2025 |
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP |
— |
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affec… |
| 2025-06-05 |
Class II
|
Ongoing |
Z-2295-2025 |
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334… |
— |
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affec… |
| 2025-06-05 |
Class II
|
Ongoing |
Z-2294-2025 |
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 |
— |
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affec… |
| 2025-06-05 |
Class II
|
Ongoing |
Z-2293-2025 |
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C |
— |
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affec… |
| 2025-03-14 |
Class II
|
Ongoing |
Z-1641-2025 |
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca… |
— |
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| 2025-03-14 |
Class II
|
Ongoing |
Z-1640-2025 |
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly |
— |
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| 2025-01-27 |
Class II
|
Ongoing |
Z-1434-2025 |
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D |
— |
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0062-2025 |
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M… |
— |
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0061-2025 |
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF… |
— |
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0060-2025 |
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto… |
— |
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0059-2025 |
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injec… |
— |
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0058-2025 |
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In… |
— |
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| 2024-08-30 |
Class II
|
Ongoing |
Z-0057-2025 |
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3… |
— |
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0073-2025 |
StabiliT TOUCH Syringe, REF: IN8VCF/B |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0072-2025 |
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0071-2025 |
basixSKY Inflation Device, REF: SKY1802 |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0070-2025 |
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410… |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0069-2025 |
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0068-2025 |
BlueFIRE Inflation Device, REF: IN10140 |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0067-2025 |
IntelliSystem Inflation Device, REF: IN1525/D |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0066-2025 |
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0065-2025 |
basixTOUCH Inflation Device, REF: IN8140/A |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-19 |
Class II
|
Ongoing |
Z-0064-2025 |
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C |
— |
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which coul… |
| 2024-08-12 |
Class II
|
Ongoing |
Z-3191-2024 |
Custom Procedure Kit, REF: K12T-11077 |
— |
7F sheath introducers labeled as 7.5F |
| 2024-08-12 |
Class II
|
Ongoing |
Z-3190-2024 |
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) |
— |
7F sheath introducers labeled as 7.5F |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2579-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2578-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2577-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2576-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2575-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2574-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2573-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2572-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2571-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2570-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReS… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2569-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC … |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2568-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2567-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2566-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2565-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2564-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2563-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2562-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2561-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2560-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2559-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Out… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2558-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-06-11 |
Class II
|
Ongoing |
Z-2557-2024 |
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rap… |
— |
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee… |
| 2024-05-22 |
Class II
|
Ongoing |
Z-2218-2024 |
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S … |
— |
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to… |
| 2024-03-14 |
Class II
|
Ongoing |
Z-1875-2024 |
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY |
— |
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. |
| 2024-03-14 |
Class II
|
Ongoing |
Z-1874-2024 |
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY |
— |
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. |
| 2023-11-06 |
Class II
|
Ongoing |
Z-0629-2024 |
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY |
— |
The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2023-11-06 |
Class II
|
Ongoing |
Z-0628-2024 |
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE… |
— |
The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2023-11-06 |
Class II
|
Ongoing |
Z-0627-2024 |
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2… |
— |
The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1920-2023 |
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1919-2023 |
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1918-2023 |
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1917-2023 |
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1916-2023 |
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1915-2023 |
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1914-2023 |
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1913-2023 |
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only |
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There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1912-2023 |
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1911-2023 |
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1910-2023 |
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1909-2023 |
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-04-22 |
Class II
|
Ongoing |
Z-1908-2023 |
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only |
— |
There is a potential that valve assemblies will not open. preventing fluid from draining. |
| 2023-03-21 |
Class II
|
Ongoing |
Z-1578-2023 |
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units |
— |
Custom sheath Introducer contains incorrect needle size |
| 2023-02-15 |
Class II
|
Ongoing |
Z-1352-2023 |
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A |
— |
Product that was built for design verification testing was inadvertently distributed to customers. |
| 2022-08-03 |
Class II
|
Ongoing |
Z-0138-2023 |
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA… |
— |
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when trigger… |
| 2022-08-03 |
Class II
|
Ongoing |
Z-0137-2023 |
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/… |
— |
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when trigger… |
| 2022-03-01 |
Class II
|
Ongoing |
Z-0904-2022 |
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B… |
— |
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get c… |
| 2022-03-01 |
Class II
|
Ongoing |
Z-0903-2022 |
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G… |
— |
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get c… |
| 2021-07-21 |
Class II
|
Terminated |
Z-2243-2021 |
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm),… |
— |
There is a potential that a package sheath contains an incorrect dilator. |
| 2021-06-30 |
Class II
|
Terminated |
Z-2239-2021 |
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, … |
— |
There is a potential that 7F sheaths are packaged as 10F sheaths. |
| 2021-06-30 |
Class II
|
Terminated |
Z-2238-2021 |
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Onl… |
— |
There is a potential that 7F sheaths are packaged as 10F sheaths. |
| 2021-06-10 |
Class II
|
Terminated |
Z-2166-2021 |
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or othe… |
— |
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. |
| 2021-01-19 |
Class II
|
Terminated |
Z-1263-2021 |
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inn… |
— |
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle i… |
| 2021-01-19 |
Class II
|
Terminated |
Z-1262-2021 |
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inn… |
— |
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle i… |
| 2020-11-10 |
Class II
|
Terminated |
Z-0751-2021 |
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For… |
— |
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposu… |
| 2020-11-10 |
Class II
|
Terminated |
Z-0750-2021 |
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 … |
— |
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposu… |
| 2020-11-10 |
Class II
|
Terminated |
Z-0749-2021 |
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/an… |
— |
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposu… |
| 2020-09-16 |
Class II
|
Terminated |
Z-0456-2021 |
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for t… |
— |
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyar… |
| 2020-09-16 |
Class II
|
Terminated |
Z-0455-2021 |
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Un… |
— |
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyar… |
| 2020-09-16 |
Class II
|
Terminated |
Z-0454-2021 |
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 u… |
— |
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyar… |
| 2020-03-11 |
Class II
|
Terminated |
Z-1796-2020 |
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT |
— |
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to… |
| 2020-02-13 |
Class II
|
Terminated |
Z-2068-2020 |
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog… |
— |
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on… |
| 2020-02-13 |
Class II
|
Terminated |
Z-2067-2020 |
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog numb… |
— |
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on… |