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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

CooperSurgical HSG Trays and Endosee Kits Recalled for Mislabeled Iodine

Agency Publication Date: July 18, 2025
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Summary

CooperSurgical, Inc. has recalled 1,637 units of HSG Procedure Trays and Endosee System Convenience Kits because they contain non-sterile iodine pouches that are incorrectly labeled as sterile. The recall affects Model Numbers 6050T, ES-TRAY, and ES-TRAY-IV. Using these products could introduce contaminants during sensitive medical procedures.

Risk

The iodine pouches included in these trays are not sterile, despite the labels claiming they are. This poses a risk of infection or other complications to patients if the non-sterile iodine is used during hysterosalpingography or sonohysterography procedures.

What You Should Do

  1. This recall involves CooperSurgical HSG Procedure Trays (Model 6050T) and Endosee System Convenience Kits (Models ES-TRAY and ES-TRAY-IV).
  2. Check your medical inventory for Model Numbers 6050T, ES-TRAY, or ES-TRAY-IV with specific lot numbers such as 339331, 335995, or 344355. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled trays and kits immediately.
  4. Contact CooperSurgical, Inc. or your medical supply distributor to arrange for the return, replacement, or correction of the affected units.
  5. For additional information or to report concerns, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: HSG Procedure Tray
Model / REF:
6050T
Lot Numbers:
339331
339327
339333
339334
343007
UDI:
60888937003262

The tray is for use in hysterosalpingography and sonohysterography procedures.

Product: Endosee System Convenience Kit
Model / REF:
ES-TRAY
Lot Numbers:
335995
339340
339341
339342
339343
339344
339345
343008
UDI:
60888937027268
Product: Endosee System Convenience Kit with IV Tube
Model / REF:
ES-TRAY-IV
Lot Numbers:
344355
550009229
550009230
550009590
550013213
UDI:
60888937026674

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97028
Status: Active
Manufacturer: CooperSurgical, Inc.
Sold By: Distributors; Medical Device Channels
Manufactured In: United States
Units Affected: 3 products (171 units; 991 units; 475 units)
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, District of Columbia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.