CooperSurgical, Inc.: Device Recall
Recall #Z-2135-2025 · 06/11/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2135-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- CooperSurgical, Inc.
- Status
- Ongoing
- Date Initiated
- 06/11/2025
- Location
- Trumbull, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171 units
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.
Product Description
HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
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.
Other Recalls by CooperSurgical, Inc.
- Class II: Risk 06/11/2025
- Class II: Risk 06/11/2025
- Class II: Risk 11/15/2024
- Class II: Risk 11/15/2024
- Class II: Risk 11/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.