PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 26, 2025 Initiated: December 16, 2024 #Z-1197-2025

Product Description

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, 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.

Details

Units Affected
4 units
Distribution
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Location
Minnetonka, MN

Frequently Asked Questions

What product was recalled?
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia. Recalled by Augustine Temperature Management, LLC. Units affected: 4 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2025. Severity: Moderate. Recall number: Z-1197-2025.