The Recall Desk
LowFDA (Devices)·Z-0208-2015·Announced 2014-11-19

CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date

CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III and involves a packaging-only documentation error (incorrect expiration date) with no reported adverse health consequences.

Plain-English summary

CooperSurgical, Inc. is recalling 6 units of MILEX Pessary Kits, specifically the Hodge w/Support Folding Pessary #1 (Model MXKPHS01). The recall is due to an incorrect expiration date printed on the product packaging.

The affected units are from Lot Number 142921. These devices were distributed in the United States to the states of Ohio, California, Wisconsin, Washington, Florida, Minnesota, New Hampshire, Rhode Island, Massachusetts, Illinois, Michigan, Iowa, and Alabama.

Consumers who have purchased these specific pessary kits should stop using them and contact CooperSurgical, Inc. for further instructions or a replacement.

The recalled product

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
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 142921

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 2 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →