FDA Device recall Z-2137-2025
Endosee System Convenience Kit with IV Tube
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Endosee System Convenience Kit with IV Tube by Coopersurgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-11 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Reason
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.
Identifiers
| code_info | Model Number: ES-TRAY-IV. UDI-DI: 60888937026674. Lot Numbers: 344355, 550009229, 550009230, 550009590, 550013213. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2025%22
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