Medical Device Recall: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Augustine Temperature Management, LLC · December 16, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
States Affected
NATIONWIDE
Quantity Affected
3 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1199-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.