CLASS II ONGOING Device recall · Reported 25 Dec 2024 · FDA Enforcement Report
Augustine Surgical Inc. Hot Dog Patient Warming recalled
Augustine Temperature Management is recalling Augustine Surgical Inc. Hot Dog Patient Warming, Temperature Management Controller. The recall was initiated on 4 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0701-2025
- FDA event ID
- 95703
- Recalling firm
- Augustine Temperature Management, Minnetonka, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2024
- FDA classified
- 18 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Surgical Instruments
Timeline
| 4 Dec 2024 | Recall initiated by company | |
| 18 Dec 2024 | Classified by FDA | +14 days |
| 25 Dec 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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".
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
US and Canada
Questions about this recall
Why was it 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".
Which lots are affected?
1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; 2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; 3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065
Where was it sold?
US and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95703| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hillrom Temperature Management Controller, MP recalled | Augustine Temperature Management | Temperature Abuse | MN | |
| CLASS II | Augustine Surgical Inc. Hot Dog Patient Warming recalled | Augustine Temperature Management | Temperature Abuse | MN |
More recalls from Augustine Temperature Management
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Augustine Surgical Inc. HotDog Return Electrode accessory recalled | Augustine Temperature Management | Other | AL, NV, TX |
| Device | CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide |
| Device | CLASS II | Augustine Surgical Inc. HotDog Return Electrode accessory recalled | Augustine Temperature Management | Other | AL, NV, TX |
| Device | CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide |
| Device | CLASS II | Hot Dog Patient Warming, Underbody Warming Mattress + recalled | Augustine Temperature Management | Other | Nationwide |
Other Surgical Instruments recalls
All 3,883| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled | ASP Global | Device Malfunction | Nationwide |
| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |