CooperSurgical, Inc. Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00888937017762, Part Numbers: 64-600
Products Sold
UDI-DI: 00888937017762; Part Numbers: 64-600
CooperSurgical, Inc. is recalling Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 due to During the manufacturing process the devices were laser-marked with the incorrect part number.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During the manufacturing process the devices were laser-marked with the incorrect part number.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026