Class II — Augustine Temperature Management, LLC
| Recalling firm | Augustine Temperature Management, LLC |
|---|---|
| Registered facility | Augustine Temperature Management, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of TX, AL, NV; AU, NZ. |
| Initiated | 2024-12-16 |
| Classified | 2025-02-20 |
| Recall number | Z-1199-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Augustine Temperature Management, LLC (Z-1199-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96155/
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