Augustine Temperature Management, LLC recalls Augustine Surgical Inc. HOT DOG PATIENT WARMING

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".

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.

Augustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.

• FDA enforcement recordOfficial FDA database entry for Z-0839-2025
• FDA 510(k) clearance · K201779The device's official FDA premarket clearance record
• FDA 510(k) clearance · K220941The device's official FDA premarket clearance record
• FDA device classification · DWJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Augustine Temperature Management, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.