CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Thermalon Stye Compress recalled by Bruder Healthcare Company
Bruder Healthcare is recalling Thermalon Stye Compress, 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-1365-2024
- FDA event ID
- 94120
- Recalling firm
- Bruder Healthcare, 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 Stye Compress, Item Number 24352
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
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 041533243526, Lot Numbers: M058520
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 94120| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Thermalon Sinus Compress (French) recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | Thermalon Back Wrap recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | Thermalon Sinus Compress recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | Thermalon Neck Wrap recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | MediBeads Neck Wrap recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | Thermalon Eye Compress recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | MediBeads King Pad recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide | |
| CLASS II | Thermalon Heating Pad recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide |
More recalls from Bruder Healthcare
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Thermalon Heating Pad recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide |
| Device | CLASS II | MediBeads King Pad recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide |
| Device | CLASS II | Thermalon Eye Compress recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide |
| Device | CLASS II | MediBeads Neck Wrap recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide |
| Device | CLASS II | Thermalon Neck Wrap recalled by Bruder Healthcare Company | Bruder Healthcare | Mold | Nationwide |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |