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Open, Classified

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

FDA Recall Z-1197-2025 · Posted 2025-02-20

Recalling FirmAugustine Temperature Management, LLC
Recall StatusOpen, Classified
Product CodeDWJ
Date Initiated2024-12-16
Product Quantity4 units

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.

Firm Action

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

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K230866HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC · 2023-06-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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