FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Stainless Steel Sims Uterine Sound, Part Number 64-601
- Recall number
- Z-3189-2024
- Recalling firm
- CooperSurgical, Inc.
- Product
- Stainless Steel Sims Uterine Sound, Part Number 64-601
- Status
- Open, Classified
- Initiated
- 2024-07-31
- Posted
- 2024-09-20
- Terminated
- not on file
- Reason
- During the manufacturing process the devices were laser-marked with the incorrect part number.
- Root cause
- Process control
- Action
- An URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE notification letter dated 7/31/24 was sent to customers. Actions to be Taken: For CUSTOMERS and DISTRIBUTORS: " Inspect your inventory for any of this Product. Product Number and other information can be found on the box and package labeling. " Please complete the included Customer Acknowledgment Form and send it via email to Recall@coopersurgical.com to complete this action. For CUSTOMERS: " If your clinic or health system has multiple locations, and you wish to report for multiple physical locations, please indicate which physical locations in the response. For DISTRIBUTORS: " If the Product has been distributed to your customers, send a copy of this letter and the Customer Acknowledgement Form to each of these customers. Please report any adverse events to your local Regulatory Authority as well as to CooperSurgical. Our email address is Recall@coopersurgical.com. You may also reach us at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 17:00 M-F EDT.
- Quantity
- 657 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
- Lot, serial or model codes
- UDI-DI: 00888937017779; Part Numbers: 64-600
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HHM
- 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