CooperSurgical Dilator/Sound Set Recalled for Potential Sterile Pouch Seal Compromise
CooperSurgical is recalling 1,740 units of Dilator/Sound Sets because the sterile pouch seal may be compromised, potentially affecting sterility.
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 classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential loss of sterility, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
CooperSurgical, Inc. is recalling 1,740 units (174 boxes) of the Dilator/Sound Set, P/N MX21, Lot # 257589. The recall is due to a potential compromise in the seal of the sterile pouch, which may affect the sterility of the device.
The affected product is a prescription-only, sterile/EO medical device made in South Korea. It was distributed to North America, including specific states such as AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WI.
Healthcare providers and consumers should stop using the affected product and contact CooperSurgical, Inc. for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
- Manufacturer
- CooperSurgical, Inc.
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 (1)
- Lot # 257589
Distribution
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