FDA Medical devices recall ·
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode… recall
- Recall number
- Z-1197-2025
- Date
- (initiated December 16, 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
- 4 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Why was it recalled?
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
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 UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297
Distribution
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
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-1197-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.