Thermalon Sinus Compress Recalled for Potential Mold and Mildew
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
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 a risk-of-harm product (medical device applied to face and sinus area with potential mold exposure) where no illnesses or injuries have been reported. The hazard is theoretical rather than confirmed contamination. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Bruder Healthcare Company, LLC is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) distributed nationwide in the US and Canada. The recall affects lot numbers M053160 and M053570.
The products may have been exposed to excessive moisture, which could result in mold and/or mildew growth. This is a Class II medical device recall.
No illnesses or injuries have been reported as of the recall announcement. Consumers who have purchased affected lots should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Thermalon Sinus Compress, Item Number 24332
- Manufacturer
- Bruder Healthcare Company, LLC
- Category
- Medical Device — Sinus Therapy
- Hazard
- Affected units
- 1,416
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: M053160
- M053570
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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