Endosee System Convenience Kit. Model Number: ES-TRAY recallZ-2136-2025 · CooperSurgical, Inc. · initiated Jun 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2136-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 11, 2025
- Posted by the FDA
- Jul 18, 2025
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 991 units
- Product code
- HIB
- FDA submissions
- K920803
- 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.
Product description
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Code information (models, lots, serial numbers)
Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Endosee System Convenience Kit ES-TRAYCoopersurgical, Inc.1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K920803 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HSG Tray 6050TCoopersurgical, Inc. · Speculum, Vaginal, Nonmetal1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97028).
- Z-2135-2025 · Open, ClassifiedHSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
- Z-2137-2025 · Open, ClassifiedEndosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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