Hot Dog PATIENT WARMING recalled over mold contamination

Recall date

December 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Augustine Temperature Management, LLC recalls Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hyp…

Recall number

Z-1197-2025

FDA classification

Class II

Brand / firm

Augustine Temperature Management, LLC

Sold / distributed

US Nationwide distribution in the states of TX, AL, NV; AU, NZ.

Why it was recalled

There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

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

What was recalled

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia