FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 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
- Recall number
- Z-0207-2015
- Recalling firm
- CooperSurgical, Inc.
- Product
- CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 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
- Status
- Terminated
- Initiated
- 2014-09-30
- Posted
- 2014-11-13
- Terminated
- 2015-05-28
- Reason
- Incorrect expiration date printed on the MILEX PESSARY KIT packaging
- Root cause
- Incorrect or no expiration date
- Action
- CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. If you have any further questions, contact 203.601.5200. .
- Quantity
- 17 units
- Distribution
- US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
- Lot, serial or model codes
- Lot Number: 146351
- 510(k) numbers
- ["K904026","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