Thermalon Back Wrap Recalled for Potential Mold and Mildew Growth
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall where certain lots may contain potential mold and mildew growth. No illnesses or injuries have been reported, but this represents a risk-of-harm product (therapeutic heating device) where injury has not yet been reported, per the severity rubric.
Plain-English summary
Thermalon Back Wrap, Item Number 24312, is being recalled due to potential mold and mildew growth. Certain lots of this heating device may have been exposed to excessive moisture.
The affected product is distributed nationwide in the United States and in Canada. This recall involves approximately 193 units with UPC 041533243120 from lot numbers M053210, M053580, and M055910.
Consumers who have purchased this product should stop using it immediately. Contact the manufacturer or a healthcare provider if you have any questions or concerns.
The recalled product
- Product
- Thermalon Back Wrap, Item Number 24312
- Manufacturer
- Bruder Healthcare Company, LLC
- Affected units
- 193
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 (4)
- UPC 041533243120
- Lot Numbers: M053210
- M053580
- M055910
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Bruder Healthcare Company, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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