CooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error
CooperSurgical is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators because the outer carton labels contain an incorrect expiration date.
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 involves a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
CooperSurgical, Inc. is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators (P/N MX20, Lot 156966). The recall was initiated because the outer carton kit labels display an incorrect expiration date.
The affected products were distributed nationwide in the states of California, Florida, Georgia, Hawaii, Illinois, Kentucky, Maryland, Minnesota, North Carolina, New York, Ohio, Texas, Vermont, and Washington. These medical devices are used for progressive vaginal dilation therapy to treat vaginismus and conditions resulting in constriction of the vaginal and/or rectal orifice.
Consumers who have these specific kits should stop using them and contact CooperSurgical, Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 40
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 156966
Distribution
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