Hot Dog PATIENT WARMING, Underbody Warming Mattress +… recallZ-1198-2025 · Augustine Temperature Management, LLC · initiated Dec 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Augustine Temperature Management, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.
Recall details
- Recall number
- Z-1198-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 16, 2024
- Posted by the FDA
- Feb 20, 2025
- Recalling firm
- Augustine Temperature Management, LLC
- Quantity
- 1 unit
- Product code
- DWJ
- Distribution
- US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Product description
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Code information (models, lots, serial numbers)
UDI-DI UDI-DI 00855913001824, Serial Numbers: 1304283
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") U502Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96155).
- Z-1197-2025 · Open, ClassifiedHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
- Z-1199-2025 · Open, ClassifiedHot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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