CooperSurgical, Inc. recalls Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

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.

CooperSurgical notified consignees on about 06/11/2025 via letter sent through certified mail. Specifically, consignees that are physicians or medical facilities were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. Distributors were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. They were also instructed to notify customers if the product was further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-2136-2025
• FDA 510(k) clearance · K920803The device's official FDA premarket clearance record
• FDA device classification · HIBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.4530The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CooperSurgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.