FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Recall number
- Z-2137-2025
- Recalling firm
- CooperSurgical, Inc.
- Product
- Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Status
- Open, Classified
- Initiated
- 2025-06-11
- Posted
- 2025-07-18
- Terminated
- not on file
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 475 units
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.
- Lot, serial or model codes
- Model Number: ES-TRAY-IV. UDI-DI: 60888937026674. Lot Numbers: 344355, 550009229, 550009230, 550009590, 550013213.
- 510(k) numbers
- ["K920803"]
- PMA numbers
- not on file
- Product code
- HIB
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28