Thermalon Sinus Compress Recalled for Potential Mold and Mildew Growth
Bruder Healthcare Company is recalling certain lots of Thermalon Sinus Compress due to potential mold and mildew growth from moisture exposure. The product was distributed in the US and Canada.
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 is an FDA Class II recall for a medical device with potential biological contamination (mold and mildew). Although no illnesses or injuries have been reported, the product presents a risk of harm, as mold growth on a facial sinus compress could potentially trigger allergic reactions or respiratory issues.
Plain-English summary
Bruder Healthcare Company, LLC is recalling Thermalon Sinus Compress (French), Item Number 24332F, from lots M053600 and M053340 (UPC 041533243328). Approximately 2,160 units of this product may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
The recalled product was distributed nationwide throughout the United States and in Canada.
The recalled product
- Product
- Thermalon Sinus Compress (French), Item Number 24332F
- 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 041533243328
- Lot Numbers: M053600
- M053340
Distribution
Distributed nationwide across the United States.
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