Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth
Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed 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: This is an FDA Class II recall for potential microbial contamination (mold and mildew) with no reported illnesses or injuries. The recall meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as mold and mildew exposure to the eye area poses a potential health risk.
Plain-English summary
Bruder Healthcare Company, LLC is recalling Thermalon Eye Compress, Item Number 2434, from certain lots due to potential mold and mildew growth. Approximately 2400 units with lot code M056410 are affected.
The compressed packs may have been exposed to excessive moisture, creating conditions for potential mold and mildew growth.
The affected products were distributed nationwide throughout the United States and in Canada.
Consumers with the affected product should discontinue use and contact Bruder Healthcare Company with any questions or concerns.
The recalled product
- Product
- Thermalon Eye Compress, Item Number 2434
- Manufacturer
- Bruder Healthcare Company, LLC
- Affected units
- 2,400
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 041533243427
- Lot Codes: M056410
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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