FDAClass IIApril 3, 2024

Thermalon Sinus Compress recall: Mold

Thermalon Sinus Compress (French), Item Number 24332F

Why was Thermalon Sinus Compress recalled?

Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UPC 041533243328, Lot Numbers: M053600, M053340

Product
Thermalon Sinus Compress (French), Item Number 24332F
Recalling firm
Bruder Healthcare Company, LLC
Quantity
2160 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
April 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls