Z-0701-2025Class II

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1)...

Name: Z-0701-2025 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1)...
Creator: Augustine Temperature Management, LLC
Published: 2024-12-04
License: https://open.fda.gov/license/

Augustine Temperature Management, LLC / initiated 2024-12-04 / Open, Classified / root cause: design

FDA source

Augustine Temperature Management, LLC began a recall of Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model #... on 2024-12-04. FDA classified it as Class II and gives the reason as "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"". 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-0701-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-04
Posted: 2024-12-18
Recalling firm: Augustine Temperature Management, LLC
Product: 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 Blankets and Mattresses.
Product code: DWJ System, Thermal Regulating
Reason for recall: 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".
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1776 units
Distribution: US and Canada
Product codes and lots: 1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; 2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; 3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0701-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0700-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0701-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18
Z-0702-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-25	2024-12-18

Product code DWJ

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)