ClearanceBrief
Recall Z-1171-2025 ยท DWJ System, Thermal Regulating

Augustine Temperature Management, LLC

Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.

DateFeb 14, 2025 (initiated Feb 15, 2024)
StatusOpen, Classified
ReasonUsers were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Root causeDevice Design
ActionAugustine 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:
Quantity20 units
DistributionUS distribution to states of: AL, TX, NV
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K210727HotDog Warming Mattress + Return Electrode
Augustine Temperature Management, LLC, Feb 1, 2022
K230866HotDog Warming Mattress + Return Electrode
Augustine Temperature Management, LLC, Jun 29, 2023