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CooperSurgical, Inc.

CooperSurgical, Inc. Recalls

All product recalls associated with CooperSurgical, Inc..

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Recall Summary

Total Recalls

22

Past Year

2

Class I (Serious)

0

Most Recent

Jun 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 22 recalls

HSG Procedure Tray (CooperSurgical) – Iodine Pouch Labeling (2025)

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

Endosee Convenience Kit (CooperSurgical) – Iodine Pouch Labeling (2025)

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

FDAJun 11, 2025Nationwide• CooperSurgical, Inc.

K-Systems G73 Dry Bath Incubator (CooperSurgical) – Temperature Excess (2024)

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

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Moderate

FDANov 15, 2024CA, DE, ID +12 more• CooperSurgical, Inc.

CooperSurgical, Inc.: Stainless Steel Sims Uterine Sound, Part Number 64-601

During the manufacturing process the devices were laser-marked with the incorrect part number.

FDAJul 31, 2024Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

During the manufacturing process the devices were laser-marked with the incorrect part number.

FDAJul 31, 2024Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Origio Sperm Wash Medium Pack of Ten 10ml bottles - Inten...

Low concentration of sodium pyruvate in the wash could compromise gamete development

FDAFeb 16, 2024Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG...

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 blastocyst stage.

FDADec 20, 2023Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Box as labeled: Regard, Carter-Thomason CloseSure System ...

Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.

FDAAug 29, 2023Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Global Total LP single step medium, 60mL, bicarbonate-buf...

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 contain the protein source required for embryo culture and development.

FDAFeb 13, 2023Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for...

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 embryo.

FDADec 15, 2022GA• CooperSurgical, Inc.

CooperSurgical, Inc.: NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

Laceration Risk

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 the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.

FDAOct 20, 2022Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Humidifier bottle and syringe filter kit (6 count of each...

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. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.

FDAAug 12, 2022AL, AZ, CA +22 more• CooperSurgical, Inc.

CooperSurgical, Inc.: LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

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 rather than the correct 5 seconds as indicated in the English version.

FDAJun 13, 2022AL, AZ, CA +28 more• CooperSurgical, Inc.

CooperSurgical, Inc.: VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The Vitr...

Products in this lot may have compromised barrier seals, introducing a risk to sterility.

FDAApr 1, 2022AZ, CA, FL +7 more• CooperSurgical, Inc.

CooperSurgical, Inc.: CooperSurgical H/S CATHETER SET FR 5 with Integated Style...

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

FDAMar 31, 2022Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administ...

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

FDAMar 31, 2022Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Quantum 2000 Electrosurgical Generators Cooper Surgical P...

XXX

FDASep 29, 2021Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: LEEP PRECISION Integrated System, 120V CooperSurgical par...

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 medical intervention to control any intraoperative bleeding and complete the case.

FDASep 29, 2021Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: LEEP PRECISION Generator 120V Cooper Surgical Part Number...

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 medical intervention to control any intraoperative bleeding and complete the case.

FDASep 29, 2021Nationwide• CooperSurgical, Inc.

CooperSurgical, Inc.: Quantum 2000 Electrosurgical Generators Cooper Surgical P...

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 medical intervention to control any intraoperative bleeding and complete the case.

FDASep 29, 2021Nationwide• CooperSurgical, Inc.