Omniflex Diaphragm — Class II medical device recall Z-1018-2013
Terminated recall by Cooper Surgical, Inc., reported 2013-04-03, distributed in AZ, CA, FL, MA, ME, MO, NE, NH…. Incorrect size was printed on the outer product packaging.
| Recall number | Z-1018-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cooper Surgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-03-04 |
| Distributed | AZ, CA, FL, MA, ME, MO, NE, NH, NM, NY, OK, PA, SC, TN, TX |
| Countries outside the US | CA, DE, IT |
| Quantity | 80 individual |
| Lot numbers | 113367 |
| Model numbers | MXWF65 |
Product
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Reason for recall
Incorrect size was printed on the outer product packaging.
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-1018-2013. 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.