Alpharetta, GA, United States
Bruder Healthcare Company, LLC recalls
1 recall recorded since 2018, most recently on 21 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 February 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1365-2024, Z-1360-2024, Z-1362-2024, Z-1361-2024, Z-1363-2024, Z-1366-2024, Z-1359-2024, Z-1367-2024, Z-1364-2024
- Thermalon Stye Compress, Item Number 24352
- Thermalon Sinus Compress (French), Item Number 24332F
- Thermalon Back Wrap, Item Number 24312
- Thermalon Sinus Compress, Item Number 24332
- Thermalon Neck Wrap, Item Number 24322
- MediBeads Neck Wrap, Item Number 34320
- Thermalon Eye Compress, Item Number 2434
- MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
- and 1 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.