CLASS II ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report
Augustine Surgical Inc. HotDog Return Electrode accessory recalled
Augustine Temperature Management is recalling Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, distributed in Alabama, Nevada, Texas. The recall was initiated on 15 Feb 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-1171-2025
- FDA event ID
- 95914
- Recalling firm
- Augustine Temperature Management, Minnetonka, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Feb 2024
- FDA classified
- 14 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 15 Feb 2024 | Recall initiated by company | |
| 14 Feb 2025 | Classified by FDA | +365 days |
| 26 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Product as listed by the FDA
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Where it was distributed
US distribution to states of: AL, TX, NV
Questions about this recall
Why was it recalled?
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Which lots are affected?
UDI-DI 00855913001794, Lot Number 2122
Where was it sold?
US distribution to states of: AL, TX, NV
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
1 other product · FDA event 95914This product is part of a recall event; the main page for the event is Augustine Surgical Inc. HotDog Return Electrode accessory recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Augustine Surgical Inc. HotDog Return Electrode accessory recalled | Augustine Temperature Management | Other | AL, NV, TX |
More recalls from Augustine Temperature Management
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Augustine Surgical Inc. Hot Dog Patient Warming recalled | Augustine Temperature Management | Temperature Abuse | MN |
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| Device | CLASS II | Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Packaging Defects | Nationwide |
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| 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 |