Augustine Temperature Management, LLC
United StatesFDA applicant, unverified FDA FEI 3005857264
Augustine Temperature Management, LLC is a medical device manufacturer, with 50 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 13 FDA recalls as of 13 Nov 2026.
- Devices
- 50
- Registrations
- FDA
- FDA recalls
- 138 ongoing
Registry facts
- Registries
- FDA GUDID 45
- FDA 510(k) 5
- Device classes
- FDA Class II 44
- FDA Class I 6
- FDA recalls
- Identifiers
- FDA FEI 3005857264
- DUNS 965879187
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 50 devicesCompany details
- FDA FEI number
- 3005857264
- DUNS number
- 965879187
- Address
- 15305 Minnetonka Blvd, Minnetonka, MN, 55345
- Website
- www.hotdogwarming.com
- facebook.com/AugustineSurgical
- cs@augbiomed.com
- Phone
- 952-746-1720
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 5
- 2023 0
- 2024 8
- 2025 0
- 2026 0
2024
- 16 Dec 2024 Z-1197-2025 Class II Ongoing 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.
- 16 Dec 2024 Z-1198-2025 Class II Ongoing 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.
- 16 Dec 2024 Z-1199-2025 Class II Ongoing 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.
- 4 Dec 2024 Z-0700-2025 Class II Ongoing 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".
- 4 Dec 2024 Z-0701-2025 Class II Ongoing 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".
- 4 Dec 2024 Z-0702-2025 Class II Ongoing 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".
- 15 Feb 2024 Z-1171-2025 Class II Ongoing Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- 15 Feb 2024 Z-1172-2025 Class II Ongoing Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
2022
- 14 Mar 2022 Z-0839-2025 Class II Completed 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".
- 14 Mar 2022 Z-0840-2025 Class II Completed 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".
Show all 13 recalls
2022
- 14 Mar 2022 Z-0841-2025 Class II Completed 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".
- 14 Mar 2022 Z-0842-2025 Class II Completed 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".
- 14 Mar 2022 Z-0843-2025 Class II Completed 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".
From the company website
HotDog’s air-free patient warming system maintains normothermia without forced-air risks and waste. Safer, cleaner, proven effective.
Frequently asked questions
How many devices does Augustine Temperature Management, LLC have in the registry?
The registry currently lists 50 devices for Augustine Temperature Management, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Augustine Temperature Management, LLC's devices?
Among its 50 most recently registered devices, Augustine Temperature Management, LLC has devices listed in FDA 510(k) (5 devices) and FDA GUDID (45 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Augustine Temperature Management, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Augustine Temperature Management, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Augustine Temperature Management, LLC?
FDA recall records list 13 recalls initiated by Augustine Temperature Management, LLC, the most recent initiated on 16 Dec 2024. 8 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Augustine Temperature Management, LLC in the registry?
The most recently registered devices listed for Augustine Temperature Management, LLC include Hillrom powered by Augustine Surgical HD 2089153, Hot Dog Patient Warming System Demo Equipment WC02D, Hot Dog Lower Body Warming Blanket B103 and HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") U502.