Thermalon Stye Compress recalled due to potential mold and mildew
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
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 FDA Class II medical device recall involves a risk-of-harm product where potential mold and mildew contamination could affect eye safety. The hazard is theoretical rather than confirmed, and no illnesses or injuries have been reported, placing it at the maximum score for recalls without reported adverse events.
Plain-English summary
Bruder Healthcare Company, LLC is recalling Thermalon Stye Compress (Item Number 24352, UPC 041533243526) due to potential growth of mold and mildew. The products may have been exposed to excessive moisture, creating conditions for microbial growth.
The recalled product has been distributed nationwide in the United States and in Canada under lot number M058520.
Mold and mildew growth on a heat compress applied near the eye could pose a health risk to users. To date, no illnesses or injuries have been reported in connection with this recall.
Consumers who have purchased the recalled product should stop using it immediately and contact Bruder Healthcare Company for instructions regarding return or replacement.
The recalled product
- Product
- Thermalon Stye Compress, Item Number 24352
- Manufacturer
- Bruder Healthcare Company, LLC
- Affected units
- 24
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 (2)
- UPC 041533243526
- Lot Numbers: M058520
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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