Z-0208-2015Class III

CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01

Name: Z-0208-2015 CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01
Creator: CooperSurgical, Inc.
Published: 2014-09-30
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2014-09-30 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and... on 2014-09-30. FDA classified it as Class III and gives the reason as "Incorrect expiration date printed on the MILEX PESSARY KIT packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0208-2015
Classification: Class III
Status: Terminated
Initiated: 2014-09-30
Posted: 2014-11-13
Terminated: 2015-05-28
Recalling firm: CooperSurgical, Inc.
Product: 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
Product code: HHW Pessary, Vaginal
Reason for recall: Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Root cause tag: labeling and UDI
FDA 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 in commerce: 6 units
Distribution: US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
Product codes and lots: Lot Number: 142921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0208-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0207-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-13
Z-0208-2015	Class III	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-13

Product code HHW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)