CooperSurgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2136-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 11, 2025

Date Posted: July 30, 2025

Recall Number: Z-2136-2025

Event ID: 97028

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.

Status: Ongoing

Product Quantity: 991 units

Code Information:

Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.

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.

Voluntary or Mandated:

Voluntary: Firm initiated