Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
FDA Recall Z-2136-2025 · Posted 2025-07-18
Recalling FirmCooperSurgical, Inc.
Recall StatusOpen, Classified
Product CodeHIB
Date Initiated2025-06-11
Product Quantity991 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.