Augustine Temperature Management, LLC: Device Recall
Recall #Z-1198-2025 · 12/16/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1198-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Augustine Temperature Management, LLC
- Status
- Ongoing
- Date Initiated
- 12/16/2024
- Location
- Minnetonka, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Product Description
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Distribution Pattern
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Other Recalls by Augustine Temperature Management, LLC
- Class II: Risk 12/16/2024
- Class II: Risk 12/16/2024
- Class II: Risk 12/04/2024
- Class II: Risk 12/04/2024
- Class II: Risk 12/04/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.