FDA Medical devices recall ·
Augustine Surgical Inc recall
- Recall number
- Z-1171-2025
- Date
- (initiated February 15, 2024)
- Company / brand
- Augustine Temperature Management, LLC
15305 Minnetonka Blvd, Minnetonka, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
Why was it recalled?
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00855913001794, Lot Number 2122
Distribution
US distribution to states of: AL, TX, NV
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1171-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.