CooperSurgical recalls Endosee System Convenience Kit (model ES-TRAY) due to non-sterile iodine pouches labeled as sterile. Affected units include specific lot numbers. Consumers should check their kit for correct labeling.
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.
CooperSurgical is recalling Endosee System Convenience Kits with model number ES-TRAY because the iodine pouches are non-sterile but labeled as sterile. This could lead to infection risks during medical procedures if used without proper sterilization.
The iodine pouches in the kit are non-sterile but labeled as sterile. If used in medical procedures without proper sterilization, this could lead to infections. The hazard is specific to the pouches being mislabeled rather than a direct safety issue.
Medical professionals using the Endosee System Convenience Kit for procedures are most at risk. Patients undergoing surgery with this kit may face infection risks if the iodine pouches are not properly sterilized.
Check for model number ES-TRAY on the kit. Affected units include lot numbers 335995 through 343008. The UDI-DI code 60888937027268 is also associated with these kits.
Look for the model number ES-TRAY and lot numbers 335995 to 343008 on the kit.
The iodine pouches are non-sterile but labeled as sterile, which could lead to infection risks during medical procedures.
Check the kit for model number ES-TRAY and lot numbers 335995 through 343008. If affected, contact CooperSurgical for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2136-2025 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-2136-2025 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
