Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of 3MLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Augustine Temperature Management with 13 device recalls, 5 510(k) clearances and 1 warning letter. The most recent is a device recall dated Dec 16, 2024: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), RE….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermiaClass II · There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out th | Device recalls |
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermiaClass II · There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out th | Device recalls |
| Dec 16, 2024 | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermiaClass II · There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out th | Device recalls |
| Apr 18, 2024 | HotDog Warming Mattress + Return ElectrodeK232627 · DWJ | 510(k) clearances |
| Mar 21, 2024 | Warning letter: Complaint handling, MDR reporting, Supplier controlsCDRH | Warning letters |
| Feb 15, 2024 | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and MattresClass II · Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . | Device recalls |
| Feb 15, 2024 | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and MattreClass II · Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . | Device recalls |
| Jun 29, 2023 | HotDog Warming Mattress + Return ElectrodeK230866 · DWJ | 510(k) clearances |
| Sep 23, 2022 | HotDog Temperature Management SystemK220941 · DWJ | 510(k) clearances |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; Class II · HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may | Device recalls |
| Mar 14, 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WCClass II · HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may | Device recalls |
| Mar 14, 2022 | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.Class II · HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may | Device recalls |
| Feb 1, 2022 | HotDog Warming Mattress + Return ElectrodeK210727 · GEI | 510(k) clearances |
| Sep 11, 2020 | HotDog Temperature Management ControllerK201779 · DWJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
