HotDog Temperature Management System recallZ-0700-2025 · Augustine Temperature Management, LLC · initiated Dec 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Augustine Temperature Management, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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".
FDA root cause category: Device Design
What the company is doing
Augustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. If the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. An optional power board update is available. For questions or concerns, contact: [email protected] or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
Recall details
- Recall number
- Z-0700-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 4, 2024
- Posted by the FDA
- Dec 18, 2024
- Recalling firm
- Augustine Temperature Management, LLC
- Quantity
- 135 units
- Product code
- DWJ
- FDA submissions
- K201779, K220941
- Distribution
- US and Canada
Product description
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.
Code information (models, lots, serial numbers)
1) UDI-DI 00850011479018, Serial Numbers: 20080004-23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080004-23060141
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HotDog Temperature Management System WC71Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K201779, K220941 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
- Hillrom powered by Augustine Surgical HD 2083516Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95703).
- Z-0701-2025 · Open, ClassifiedAugustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished);…
- Z-0702-2025 · Open, ClassifiedHillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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