Reported Jul 30, 2025 · Ongoing
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- Endosee System Convenience Kit with IV Tube
- Model NumberES-TRAY-IV. Endosee System Convenience Kit with IV Tube
- Lot codes and dates
- Model NumberES-TRAY-IV
- UDI-DI60888937026674
- Lot Numbers
344355550009229550009230550009590550013213
- Amount recalled
- 475 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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