CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling
CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.
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, and the hazard is a minor labeling error regarding product size, which fits the criteria for a moderate severity recall.
Plain-English summary
CooperSurgical, Inc. is recalling 95 units of the Pessary Kit-CUBE#2, 1-3/8 in, 35 mm (Part Number: MXKPEC02). The recall is due to an incorrect size being printed on the packaging label.
The affected products were distributed nationwide. The specific lot numbers involved are 144351 and 142789.
Consumers who have this product should check the packaging label for the incorrect size and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 95
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)
- Lot numbers: 144351
- 142789
Distribution
Distributed nationwide across the United States.
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