FDA Device recall Z-0253-2016
MILEX PESSARY KIT
- FDA Device
- Class III
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class III recall of MILEX PESSARY KIT by Coopersurgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0253-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coopersurgical |
| Distribution | US |
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
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.
Identifiers
| code_info | MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0253-2016%22
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