Class III — CooperSurgical, Inc.
| Recalling firm | COOPERSURGICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 144 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI,WV and in the countries of FRANCE and VIETNAM. |
| Initiated | 2015-09-14 |
| Classified | 2015-11-09 |
| Terminated | 2016-01-08 |
| Recall number | Z-0253-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — CooperSurgical, Inc. (Z-0253-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72204/
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