FDA recall Z-1172-2025

Augustine Temperature Management, LLC · Class II · device

Product

Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

Reason for recall

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

Distribution

US distribution to states of: AL, TX, NV

Key facts

Status
Ongoing
Initiation date
2024-02-15
Report date
2025-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1172-2025