Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Reported: July 30, 2025 Initiated: June 11, 2025 #Z-2137-2025
Product Description
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
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.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 475 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.
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.. Recalled by CooperSurgical, Inc.. Units affected: 475 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2025. Severity: Moderate. Recall number: Z-2137-2025.
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