CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Thermalon Back Wrap recalled by Bruder Healthcare Company
Bruder Healthcare Company is recalling Thermalon Back Wrap, distributed nationwide in the US. The recall was initiated on 21 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1362-2024
- FDA event ID
- 94120
- Recalling firm
- Bruder Healthcare Company, Alpharetta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Feb 2024
- FDA classified
- 22 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Mold
- Device type
- Other Medical Devices
Timeline
| 21 Feb 2024 | Recall initiated by company | |
| 22 Mar 2024 | Classified by FDA | +30 days |
| 3 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Thermalon Back Wrap, Item Number 24312
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Thermalon Back Wrap recalled?
Yes. Bruder Healthcare Company recalled Thermalon Back Wrap on 21 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1362-2024.
Why was it recalled?
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.
Which lots are affected?
UPC 041533243120, Lot Numbers: M053210, M053580, M055910
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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