Z-2136-2025Class II

Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

Name: Z-2136-2025 Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Creator: CooperSurgical, Inc.
Published: 2025-06-11
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2025-06-11 / Open, Classified / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit on 2025-06-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2136-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-11
Posted: 2025-07-18
Recalling firm: CooperSurgical, Inc.
Product: Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Product code: HIB Speculum, Vaginal, Nonmetal
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 991 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.
Product codes and lots: Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2135-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18
Z-2136-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18
Z-2137-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-18

Product code HIB

K920803Class IIHsg TrayUnimar, Inc. / cleared 1992-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)