| 2026-08-11 |
Class I
|
Ongoing |
Z-3140-2026 |
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Mod… |
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Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pre… |
| 2026-08-11 |
Class I
|
Ongoing |
Z-3139-2026 |
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Nu… |
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Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pre… |
| 2025-06-11 |
Class II
|
Ongoing |
Z-2137-2025 |
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube. |
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The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine… |
| 2025-06-11 |
Class II
|
Ongoing |
Z-2136-2025 |
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit |
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The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine… |
| 2025-06-11 |
Class II
|
Ongoing |
Z-2135-2025 |
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterog… |
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The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine… |
| 2024-11-15 |
Class II
|
Ongoing |
Z-0692-2025 |
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Pr… |
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The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value… |
| 2024-11-15 |
Class II
|
Ongoing |
Z-0691-2025 |
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Descripti… |
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The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value… |
| 2024-11-15 |
Class II
|
Ongoing |
Z-0690-2025 |
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Des… |
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The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value… |
| 2024-11-15 |
Class II
|
Ongoing |
Z-0689-2025 |
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Des… |
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The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value… |
| 2024-11-15 |
Class II
|
Ongoing |
Z-0688-2025 |
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product De… |
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The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value… |
| 2024-11-15 |
Class II
|
Ongoing |
Z-0687-2025 |
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An elect… |
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The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value… |
| 2024-07-31 |
Class II
|
Ongoing |
Z-3189-2024 |
Stainless Steel Sims Uterine Sound, Part Number 64-601 |
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During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2024-07-31 |
Class II
|
Ongoing |
Z-3188-2024 |
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 |
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During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2024-02-16 |
Class II
|
Ongoing |
Z-3298-2024 |
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D |
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Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2024-02-16 |
Class II
|
Ongoing |
Z-3297-2024 |
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A |
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Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2024-02-16 |
Class II
|
Ongoing |
Z-3296-2024 |
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A |
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Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2023-12-20 |
Class II
|
Ongoing |
Z-1089-2024 |
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult… |
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The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the … |
| 2023-08-29 |
Class II
|
Ongoing |
Z-0985-2024 |
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R… |
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Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. |
| 2023-02-13 |
Class II
|
Ongoing |
Z-1348-2023 |
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num… |
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It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contai… |
| 2022-12-15 |
Class II
|
Ongoing |
Z-1044-2023 |
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantati… |
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The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the em… |
| 2022-10-20 |
Class II
|
Ongoing |
Z-0223-2023 |
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 |
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Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where… |
| 2022-08-12 |
Class II
|
Ongoing |
Z-1823-2022 |
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246) |
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There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging.… |
| 2022-08-12 |
Class II
|
Ongoing |
Z-1822-2022 |
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Ma… |
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There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging.… |
| 2022-06-13 |
Class II
|
Ongoing |
Z-1421-2022 |
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 |
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There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rat… |
| 2022-04-01 |
Class II
|
Ongoing |
Z-1108-2022 |
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed o… |
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Products in this lot may have compromised barrier seals, introducing a risk to sterility. |
| 2022-03-31 |
Class II
|
Ongoing |
Z-0504-2024 |
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hys… |
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Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage… |
| 2022-03-31 |
Class II
|
Ongoing |
Z-0503-2024 |
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hystero… |
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Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage… |
| 2022-03-31 |
Class II
|
Ongoing |
Z-0502-2024 |
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysteroson… |
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Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0263-2022 |
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W |
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XXX |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0262-2022 |
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05 |
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Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0261-2022 |
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075 |
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Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0260-2022 |
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 |
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Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0259-2022 |
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120 |
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Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0258-2022 |
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220 |
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Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0257-2022 |
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120 |
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Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medica… |
| 2021-06-30 |
Class II
|
Terminated |
Z-2307-2021 |
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for us… |
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Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an exter… |
| 2021-04-30 |
Class II
|
Terminated |
Z-1847-2021 |
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes… |
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The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. |
| 2021-04-23 |
Class II
|
Ongoing |
Z-1686-2021 |
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade p… |
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The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. |
| 2021-01-21 |
Class II
|
Terminated |
Z-1152-2021 |
Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4"… |
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The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as requ… |
| 2020-09-08 |
Class II
|
Terminated |
Z-0100-2021 |
MediCult Vitrification Cooling Media, Model Number 12284001F |
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There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that… |
| 2020-06-03 |
Class II
|
Terminated |
Z-2498-2020 |
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176 |
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Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and th… |
| 2020-04-09 |
Class II
|
Terminated |
Z-2112-2020 |
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 |
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The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. |
| 2020-02-28 |
Class III
|
Terminated |
Z-1713-2020 |
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical I… |
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Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. |