The Recall Desk
HighFDA (Devices)·Z-1367-2024·Announced 2024-04-03

MediBeads King Pad Moist Heat Compresses Recalled for Potential Mold Growth

Bruder Healthcare is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots due to potential mold and mildew growth from excessive moisture exposure.

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: This recall involves a moist heat compress with potential mold and mildew growth that directly contacts skin. Although no illnesses have been reported, this is a risk-of-harm product where fungal infection and respiratory exposure are possible.

Plain-English summary

Bruder Healthcare Company, LLC is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots. The recall affects 585 units with lot numbers M053590 and M053280, distributed worldwide including the United States and Canada.

Certain lots of the MediBeads King Pad may have been exposed to excessive moisture, resulting in potential growth of mold and mildew. The product is a moist heat compress intended for therapeutic use applied to the skin. Exposure to mold or mildew could result in skin irritation, fungal infection, or respiratory health risks.

This is a Class II medical device recall issued by the FDA.

The recalled product

Product
MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
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 (3)

  • UPC 041533341208
  • Lot Numbers: M053590
  • M053280

Distribution

Distributed nationwide across the United States.