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RecallWatchMedical Device Safety
Class IIOngoingZ-1198-2025

Augustine Temperature Management, LLC recalls Hot Dog PATIENT WARMING

Augustine Temperature Management, LLCMinnetonka, MN, United StatesReported Feb 26, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermiaUDI
    UDI-DI UDI-DI
    Affected lot
    1304283

What the firm is doing

Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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