Endosee system convenience trays label non-sterile iodine pouches as sterile
Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.
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: Risk-of-harm product: a non-sterile component labelled as sterile could be introduced into a sterile field, with no infection reported in the source.
Plain-English summary
The Endosee System Convenience Kit, model number ES-TRAY, UDI-DI 60888937027268, is being recalled. The action covers 991 units across the lot numbers listed in the recall notice, including 335995, 339340, 339341 and 339342.
The stated reason is that 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. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was nationwide in the United States, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut and Delaware among other states. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Procedure kit
- Hazard
- mislabeled-sterility
- non-sterile-component
- iodine-pouch
- class-ii
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 (8)
- Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995
- 339340
- 339341
- 339342
- 339343
- 339344
- 339345
- 343008.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22