Recall Z-2135-2025— CooperSurgical, Inc.

Name: FDA recall Z-2135-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-11

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2025-06-11. It names one FDA 510(k) clearance: K920803. Product: HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.. 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-11
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K920803 — HSG TRAYUnimar, Inc.·cleared 1992-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.