CooperSurgical, Inc. — Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2025
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.
What's affected?
- Product
- Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
- Brand
- CooperSurgical, Inc.
- Lot code
- 335995
Additional details
Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 991 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.