CooperSurgical Recalls Incorrectly Packaged Ultem Koh Cup Vaginal Delineators
CooperSurgical is recalling specific Koh Cup vaginal delineators that were incorrectly packaged with a 3.5cm cup instead of the required 3.0cm model.
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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text, fitting the criteria for minor labeling or packaging errors.
Plain-English summary
CooperSurgical, Inc. is recalling the Ultem Polymeric Resin Koh Cup, a non-sterile, reusable vaginal fornices delineator. The affected units, identified by Lot 280819, were incorrectly packaged with a 3.5cm Ultem Koh cup (P/N 34131-04) instead of the required 3.0cm Ultem Koh cup (P/N 34131-03). The product is made of medical-grade plastics and does not contain natural rubber latex.
The recall involves 6 boxes or 12 units distributed domestically to Utah, Ohio, and Delaware. This is a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and consumers who have purchased or received these specific units should stop using them and contact CooperSurgical, Inc. for instructions on return or replacement.
The recalled product
- Product
- The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
- 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 280819
Distribution
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