MILEX PESSARY KIT — Class III medical device recall Z-0253-2016
Terminated recall by CooperSurgical, Inc., reported 2015-11-18, distributed nationwide. The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the
| Recall number | Z-0253-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-09-14 |
| Classified | 2015-11-09 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, VN |
| Quantity | 144 units |
| Reason classes | labeling |
| Lot numbers | 125143, 139411, 142853, 153096, 157299, 157364, 160432, 180533, MXKPES00, MXKPGSK07, MXKPREG03 |
| Model numbers | MXPES00 |
Product
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
Reason for recall
The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.
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-0253-2016. 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.