Cooper Surgical Incontinence Dish Folding Pessary #0 — Class III medical device recall Z-1007-2013
Terminated recall by Cooper Surgical, Inc., reported 2013-04-03, distributed nationwide. Pessary mislabeled outer package may not reflect the size of the product contained in the package
| Recall number | Z-1007-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cooper Surgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2013-03-27 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CO, FR, NL, TH |
| Quantity | 36 units |
| Reason classes | labeling |
| Lot numbers | 114288 |
| Model numbers | MXKPCOND00A |
Product
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
Reason for recall
Pessary mislabeled outer package may not reflect the size of the product contained in the package
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-1007-2013. 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.