Endosee System Convenience Kit — Class II medical device recall Z-2136-2025
Ongoing recall by CooperSurgical, Inc., reported 2025-07-30, distributed nationwide. The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the pe
| Recall number | Z-2136-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2025-06-11 |
| Classified | 2025-07-18 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Quantity | 991 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 60888937027268 |
| Lot numbers | 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008 |
Product
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2136-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.