Endosee Convenience Kit (CooperSurgical) – Iodine Pouch Labeling (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.
Products Sold
Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.
CooperSurgical, Inc. is recalling Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit due to The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
CooperSurgical notified consignees on about 06/11/2025 via letter sent through certified mail. Specifically, consignees that are physicians or medical facilities were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. Distributors were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. They were also instructed to notify customers if the product was further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026