Augustine Temperature Management, LLC: Medical Device Recall in 2025 - (Recall #: Z-1197-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 16, 2024

Date Posted: February 26, 2025

Recall Number: Z-1197-2025

Event ID: 96155

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.

Status: Ongoing

Product Quantity: 4 units

Code Information:

UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated