Z-0253-2016Class III

MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07

Name: Z-0253-2016 MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07
Creator: CooperSurgical, Inc.
Published: 2015-09-14
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-09-14 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number... on 2015-09-14. FDA classified it as Class III and gives the reason as "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...". 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-0253-2016
Classification: Class III
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-11-10
Terminated: 2016-01-08
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.
Product code: HHW Pessary, Vaginal
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0253-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0253-2016	Class III	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

Product code HHW

K904774Class IIInglat-O-BallMilex Products, Inc. / cleared 1990-12-07

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)