Stainless Steel Sims Uterine Sound Recalled for Incorrect Part Number
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.
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: FDA Class II device with a labeling error (incorrect part number marking). No injuries or illnesses have been reported. The incorrect labeling is a minor manufacturing defect that could affect device identification but poses a theoretical rather than confirmed patient safety risk.
Plain-English summary
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound, Part Number 64-601, a surgical instrument used in gynecological procedures. The company identified that 657 units were laser-marked with incorrect part numbers during the manufacturing process.
The incorrect labeling could lead to confusion when selecting the correct instrument for surgical use, creating a potential patient safety risk. The devices were distributed worldwide, including throughout the United States and to Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, and Sweden.
No injuries or adverse events have been reported to date. Healthcare facilities and providers should immediately check their inventory of the Stainless Steel Sims Uterine Sound (Part Number 64-601) to verify the laser-marked part number matches the actual product. Any units with discrepancies should be removed from use and returned to CooperSurgical, Inc. for verification and replacement.
The recalled product
- Product
- Stainless Steel Sims Uterine Sound, Part Number 64-601
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 657
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: 00888937017779
- 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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