CLASS II ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report
Hot Dog Patient Warming, Underbody Warming Mattress + recalled
Augustine Temperature Management is recalling Hot Dog Patient Warming, Underbody Warming Mattress + Return Electrode (35"), distributed nationwide in the US. The recall was initiated on 16 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1199-2025
- FDA event ID
- 96155
- Recalling firm
- Augustine Temperature Management, Minnetonka, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2024
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2024 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +66 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Where it was distributed
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI UDI-DI 00855913001848, Serial Numbers: 1304384, 1304619, 1304620
Where was it sold?
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96155This product is part of a recall event; the main page for the event is Hot Dog Patient Warming, Underbody Warming Mattress + recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide | |
| CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide |
More recalls from Augustine Temperature Management
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Augustine Surgical Inc. HotDog Return Electrode accessory recalled | Augustine Temperature Management | Other | AL, NV, TX |
| Device | CLASS II | Augustine Surgical Inc. HotDog Return Electrode accessory recalled | Augustine Temperature Management | Other | AL, NV, TX |
| Device | CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide |
| Device | CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide |
| Device | CLASS II | Augustine Surgical Inc. Hot Dog Patient Warming recalled | Augustine Temperature Management | Temperature Abuse | MN |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |