CooperSurgical, Inc.: Device Recall

Recall #Z-3189-2024 · 07/31/2024

Class II: Risk

Recall Details

Recall Number: Z-3189-2024
Classification: Class II
Product Type: Device
Recalling Firm: CooperSurgical, Inc.
Status: Ongoing
Date Initiated: 07/31/2024
Location: Trumbull, CT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 657 units

Reason for Recall

During the manufacturing process the devices were laser-marked with the incorrect part number.

Product Description

Stainless Steel Sims Uterine Sound, Part Number 64-601

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.

Other Recalls by CooperSurgical, Inc.

Class II: Risk 06/11/2025

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.
Class II: Risk 06/11/2025

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.
Class II: Risk 06/11/2025

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.
Class II: Risk 11/15/2024

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
Class II: Risk 11/15/2024

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

View all recalls by CooperSurgical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.