Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product… — Class II medical device recall Z-2098-2015
Terminated recall by CooperSurgical, Inc., reported 2015-07-29, distributed nationwide. Incorrect expiration date on outer carton kit label
| Recall number | Z-2098-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-06-19 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 40 kits |
| Reason classes | labeling |
| Lot numbers | 156966 |
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 result in constriction of the vaginal and/or rectal orifice
Reason for recall
Incorrect expiration date on outer carton kit label
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2098-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.