Z-3188-2024Class II

Silver-Plated Copper Sims Uterine Sound, Part Number 64-600

Name: Z-3188-2024 Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Creator: CooperSurgical, Inc.
Published: 2024-07-31
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2024-07-31 / Open, Classified / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a recall of Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 on 2024-07-31. FDA classified it as Class II and gives the reason as "During the manufacturing process the devices were laser-marked with the incorrect part number". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3188-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-31
Posted: 2024-09-20
Recalling firm: CooperSurgical, Inc.
Product: Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Product code: HHM Sound, Uterine
Reason for recall: During the manufacturing process the devices were laser-marked with the incorrect part number.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected]. 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 in commerce: 468 units
Distribution: Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
Product codes and lots: UDI-DI: 00888937017762; Part Numbers: 64-600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3188-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3188-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3189-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code HHM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)