CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0253-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: September 14, 2015

Date Posted: November 18, 2015

Recall Number: Z-0253-2016

Event ID: 72204

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.

Status: Terminated

Product Quantity: 144 units

Code Information:

MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated