Minnetonka, MN, United States
Augustine Temperature Management, LLC recalls
4 recalls recorded since 2018, most recently on 16 December 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 December 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1198-2025, Z-1197-2025, Z-1199-2025
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
Ongoing Class II Medical devices
- Recall started
- 4 December 2024
- Reason
- Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0701-2025, Z-0702-2025, Z-0700-2025
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Bla
- Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
Ongoing Class II Medical devices
- Recall started
- 15 February 2024
- Reason
- Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Distribution
- US distribution to states of: AL, TX, NV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1172-2025, Z-1171-2025
- Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
- Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Completed Class II Medical devices
- Recall started
- 14 March 2022
- Reason
- HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0843-2025, Z-0839-2025, Z-0841-2025, Z-0840-2025, Z-0842-2025
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinar
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
- Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming B
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veteri
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.