Z-1199-2025Class II

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or...

Name: Z-1199-2025 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or...
Creator: Augustine Temperature Management, LLC
Published: 2024-12-16
License: https://open.fda.gov/license/

Augustine Temperature Management, LLC / initiated 2024-12-16 / Open, Classified / root cause: design

FDA source

Augustine Temperature Management, LLC began a recall of Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia on 2024-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1199-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-16
Posted: 2025-02-20
Recalling firm: Augustine Temperature Management, LLC
Product: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Product code: DWJ System, Thermal Regulating
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.
Root cause tag: design
FDA root cause: Device Design
Action: Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Product codes and lots: UDI-DI UDI-DI 00855913001848, Serial Numbers: 1304384, 1304619, 1304620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1199-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1197-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1198-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1199-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20

Product code DWJ

K230866Class IIHotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC / cleared 2023-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)