FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: 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.
- Recall number
- Z-0253-2016
- Recalling firm
- CooperSurgical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-09-14
- Posted
- 2015-11-10
- Terminated
- 2016-01-08
- 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.
- Root cause
- Labeling mix-ups
- Action
- Cooper Surgical sent an Urgent Medical Device Recall letter dated September 14, 2015 via FedEx with confirmed delivery receipt. The letter identified the affected product, problem and actions to be taken. Customers were asked to discontinue use of the affected products and complete the Acknowledgement and Receipt form for a free replacement. For questions contact Product Surveillance at 203.601.5200 ext. 3300.
- 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.
- Lot, serial or model codes
- MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432
- 510(k) numbers
- ["K904774"]
- PMA numbers
- not on file
- Product code
- HHW
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28