Cooper Surgical Recalls Omniflex Diaphragms Due to Packaging Labeling Error
Cooper Surgical is recalling 80 Omniflex Diaphragms because the incorrect size was printed on the outer packaging.
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 source text identifies the issue as a minor labeling error on the packaging without reporting any illnesses or injuries.
Plain-English summary
Cooper Surgical, Inc. is recalling 80 individual Omniflex Diaphragms, Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm), Model MXWF65. The recall was initiated because the incorrect size was printed on the outer product packaging.
The affected units are from Lot 113367. These products were distributed worldwide, including in the United States and in Germany, Italy, and Canada. The diaphragms are intended for use in contraception.
Consumers who have these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
- Manufacturer
- Cooper Surgical, Inc.
- Hazard
- Affected units
- 80
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 113367
Distribution
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