Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
FDA Recall #Z-2136-2025 — Class II — June 11, 2025
Product Description
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
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.
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated