Augustine Surgical Inc. HotDog Return Electrode accessory… recallZ-1172-2025 · Augustine Temperature Management, LLC · initiated Feb 15, 2024
Class II Open, Classified All recalls posted in February 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Augustine Temperature Management, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
FDA root cause category: Device Design
What the company is doing
Augustine Temperature Management contacted their consignees by visit beginning on 02/15/2024 to replace the affected cables. The firm collected email confirmation that the original cables had either been returned or destroyed. If you have any questions, contact the Product Manager at 952-465-3526 or email:
Recall details
- Recall number
- Z-1172-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 15, 2024
- Posted by the FDA
- Feb 14, 2025
- Recalling firm
- Augustine Temperature Management, LLC
- Quantity
- 7 unit
- Product code
- DWJ
- FDA submissions
- K210727, K230866
- Distribution
- US distribution to states of: AL, TX, NV
Product description
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Code information (models, lots, serial numbers)
UDI-DI 00850011479674, Lot Number 2339
Other devices under the same FDA submission
3 devices cleared under K210727, K230866 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32") U501Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
- HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") U502Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
- HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35") U530Augustine Temperature Management LLC · System, Thermal Regulating1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95914).
- Z-1171-2025 · Open, ClassifiedAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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