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FDAJune 11, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

coopersurgical

UPCs

60888937026674

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube. — Recall Details · AllClear