CooperSurgical Recalls MILEX OMNIFLEX Diaphragms Due to Packaging Error
CooperSurgical is recalling 200 units of MILEX OMNIFLEX Diaphragms because size 80 boxes were incorrectly packaged with size 85 diaphragms.
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 involves a temporary or medically reversible adverse health consequence. The hazard is a packaging error leading to potential use of an ill-fitting device, which is a moderate risk.
Plain-English summary
CooperSurgical, Inc. is recalling 200 units of MILEX OMNIFLEX Diaphragms, Size 80, Model MXWF80. The recall involves Lot 153309. The product was distributed to Alaska, California, the District of Columbia, Florida, Illinois, Maine, Montana, Nebraska, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Virginia, Washington, Wisconsin, and foreign locations including Canada, England, and Poland.
The recall was initiated because a diaphragm size 80 labeled box was incorrectly packaged with a size 85 diaphragm. This packaging error could result in the use of a diaphragm that does not fit the user's anatomy, potentially compromising the effectiveness of the contraceptive device.
Consumers who have purchased this product should stop using it and contact CooperSurgical, Inc. for further instructions or a replacement.
The recalled product
- Product
- MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 200
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 153309
Distribution
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