The Recall Desk
ModerateFDA (Devices)·Z-1631-2022·Announced 2022-08-31

Cooper Surgical Milex Pessary Recalled for Temperature Exposure During Storage

Mckesson Medical-Surgical is recalling Cooper Surgical Milex Pessary Ring products stored at elevated temperatures from June through August 2021, which may have degraded product effectiveness.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses, injuries, or deaths. The hazard is theoretical—temperature exposure may have impacted effectiveness—rather than confirmed, and the recall appears precautionary in nature.

Plain-English summary

Cooper Surgical Milex Pessary, Ring Milex Incont Flexible Size 6 (Catalog #MXPCON06) is being recalled by Mckesson Medical-Surgical Inc. due to temperature excursions that occurred prior to delivery.

From June 2021 through August 2021, products were exposed to higher-than-appropriate temperatures during storage and handling. This temperature exposure may have impacted the product's effectiveness.

The recall affects all Milex Pessary Ring products with lot codes received between June 1, 2021 and September 30, 2021. These products were distributed nationwide in the United States.

The recalled product

Product
COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-exposure
  • product-degradation

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)

  • GTIN: 888937004427

Distribution

Distributed nationwide across the United States.