CooperSurgical MILEX PESSARY KITS recallZ-0208-2015 · CooperSurgical, Inc. · initiated Sep 30, 2014
Class III Terminated All recalls posted in November 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
FDA root cause category: Incorrect or no expiration date
What the company is doing
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. .
Recall details
- Recall number
- Z-0208-2015
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Sep 30, 2014
- Posted by the FDA
- Nov 13, 2014
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 6 units
- Product code
- HHW
- FDA submissions
- K904026, K904774
- Distribution
- US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
Product description
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 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
Code information (models, lots, serial numbers)
Lot Number: 142921
Other devices under the same FDA submission
1 device cleared under K904026, K904774 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MILEX MXFIT0023Coopersurgical, Inc. · Pessary, Vaginal1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 69500).
- Z-0207-2015 · TerminatedCooperSurgical 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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page