CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary-… — Class III medical device recall Z-0208-2015
Terminated recall by CooperSurgical, Inc., reported 2014-11-19, distributed in AL, CA, FL, IA, IL, MA, MI, MN…. Incorrect expiration date printed on the MILEX PESSARY KIT packaging
| Recall number | Z-0208-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2014-09-30 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-05-28 |
| Distributed | AL, CA, FL, IA, IL, MA, MI, MN, NH, OH, RI, WA, WI |
| Quantity | 6 units |
| Reason classes | labeling |
| Lot numbers | 142921 |
| Model numbers | MXKPHS01 |
Product
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
Reason for recall
Incorrect expiration date printed on the MILEX PESSARY KIT 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-0208-2015. 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.