Cooper Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1009-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Product Classification:

Class III

Date Initiated: February 26, 2013

Date Posted: April 3, 2013

Recall Number: Z-1009-2013

Event ID: 64531

Reason for Recall:

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Status: Terminated

Product Quantity: 275 units

Code Information:

Lot Number:117560

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated