FDA recall record · openFDA

CooperSurgical, Inc.

17 FDA recalls on record (2023–2025) — 17 device. 17 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If t 6

Low concentration of sodium pyruvate in the wash could compromise gamete development 3

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away li 3

During the manufacturing process the devices were laser-marked with the incorrect part number. 2

Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. 1

Recalls

Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube. Class II 2025-06-11 Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit Class II 2025-06-11 HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterog Class II 2025-06-11 Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product De Class II 2024-11-15 Stainless Steel Sims Uterine Sound, Part Number 64-601 Class II 2024-07-31 Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Des Class II 2024-11-15 Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D Class II 2024-02-16 Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Pr Class II 2024-11-15 Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An elect Class II 2024-11-15 Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A Class II 2024-02-16 Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Des Class II 2024-11-15 Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A Class II 2024-02-16 Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 Class II 2024-07-31 Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Descripti Class II 2024-11-15 Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R Class II 2023-08-29 Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num Class II 2023-02-13 global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult Class II 2023-12-20

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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