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Recall Observatory FDA recall evidence

Device product

Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.

Z-2137-2025

June 11, 2025

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 97028
Status
Ongoing
Classification
Class II
Quantity
475 units
Official record key
device-enforcement:Z-2137-2025

Official wording

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.

Code information: Model Number: ES-TRAY-IV. UDI-DI: 60888937026674. Lot Numbers: 344355, 550009229, 550009230, 550009590, 550013213.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.