Recall Z-1198-2025— Augustine Temperature Management, LLC

Name: FDA recall Z-1198-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-16

Class II · Ongoing

Class II FDA medical device recall by Augustine Temperature Management, LLC, initiated 2024-12-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia. Reason: 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..

Recalling firm: Augustine Temperature Management, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-12-16
Firm location: Minnetonka, MN, United States

Product description

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.