The Recall Desk
HighFDA (Devices)·Z-1366-2024·Announced 2024-04-03

MediBeads Neck Wrap recalled for potential mold and mildew growth

Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for mold and mildew contamination. This represents a risk-of-harm product where injury has not yet been reported, per the severity rubric.

Plain-English summary

Bruder Healthcare Company, LLC is recalling MediBeads Neck Wrap (Item Number 34320) due to potential mold and mildew growth resulting from exposure to excessive moisture.

The recall affects 430 units distributed nationwide in the United States and in Canada. The affected product is identified by UPC 041533343202 and Lot Number M053300.

Consumers should discontinue use of the recalled product and contact Bruder Healthcare Company, LLC regarding the recall.

The recalled product

Product
MediBeads Neck Wrap, Item Number 34320
Manufacturer
Bruder Healthcare Company, LLC
Hazard
  • mold
  • mildew

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 (2)

  • UPC 041533343202
  • Lot Numbers: M053300

Distribution

Distributed nationwide across the United States.