Medical device recalls Moderate risk

Thermalon Sinus Compress recalled over fire hazard

Recall date
February 21, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Bruder Healthcare Company, LLC recalls Thermalon Sinus Compress (French), Item Number 24332F
Recall number
Z-1360-2024
FDA classification
Class II
Brand / firm
Bruder Healthcare Company, LLC
Sold / distributed
Worldwide distribution - US Nationwide and the country of Canada.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Thermalon Sinus Compress (French), Item Number 24332F

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