Endosee System Convenience Kits recalled for non-sterile iodine pouches
CooperSurgical is recalling 475 units of Endosee System Convenience Kits with IV Tube due to non-sterile iodine pouches labeled as sterile. The kits were distributed nationwide to healthcare facilities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving non-sterile supplies used in invasive procedures. The mislabeling of non-sterile iodine pouches as sterile creates risk of harm through potential infection; no illnesses or injuries have been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 475 units of the Endosee System Convenience Kit with IV Tube (Model ES-TRAY-IV) due to a sterility issue with the included iodine pouches.
The kits contain non-sterile iodine pouches, but the peel-away lid labels incorrectly identify the pouches as sterile. This mislabeling could result in non-sterile supplies being used in procedures where sterile materials are required.
The recalled units (Model ES-TRAY-IV, UDI-DI 60888937026674) were distributed nationwide to healthcare facilities and providers in all U.S. states and Washington, D.C. The affected lot numbers are 344355, 550009229, 550009230, 550009590, and 550013213.
The recalled product
- Product
- Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- non-sterile
- infection-risk
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Number: ES-TRAY-IV. UDI-DI: 60888937026674. Lot Numbers: 344355
- 550009229
- 550009230
- 550009590
- 550013213.
Distribution
Distributed nationwide across the United States.
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