CooperSurgical Recalls Silver-Plated Copper Sims Uterine Sound for Incorrect Marking
CooperSurgical is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds because they were laser-marked with the incorrect part number during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is due to a minor labeling error (incorrect part number) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CooperSurgical, Inc. is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds, Part Number 64-600. The recall was initiated because the devices were laser-marked with the incorrect part number during the manufacturing process.
The affected devices were distributed worldwide, including in the United States and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, and Sweden. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should stop using the affected devices and contact CooperSurgical for instructions on how to return them. The UDI-DI for the affected product is 00888937017762.
The recalled product
- Product
- Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 468
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00888937017762
- Part Numbers: 64-600
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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