FDA Medical Device Recalls (openFDA)
Bruder Healthcare Company, LLC: MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
- Recall number
- Z-1367-2024
- Recalling firm
- Bruder Healthcare Company, LLC
- Product
- MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
- Status
- Open, Classified
- Initiated
- 2024-02-21
- Posted
- 2024-03-22
- Terminated
- not on file
- Reason
- Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Root cause
- Under Investigation by firm
- Action
- Bruder Healthcare Company sent an email to its consignees on XXX to notify them of the recall. The email explained the issue and requested the consignees cease distribution of affected stock and contact Bruder Healthcare Company for instructions on returning the product. Distributors were directed to forward the recall communication to their customers.
- Quantity
- 585 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- UPC 041533341208, Lot Numbers: M053590, M053280
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IMA
- Firm FEI
- 1039131
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28