Endosee System Convenience Kit recalled over sterility concerns

Recall date

June 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CooperSurgical, Inc. recalls Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

Recall number

Z-2136-2025

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit