Recall Z-2136-2025 ยท HIB Speculum, Vaginal, Nonmetal
CooperSurgical, Inc.
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
| Date | Jul 18, 2025 (initiated Jun 11, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 instr |
| Quantity | 991 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920803 | HSG TRAY Unimar, Inc., Oct 19, 1992 |