Augustine Temperature Management, LLC recalls Hot Dog PATIENT WARMING

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.

Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.

• FDA enforcement recordOfficial FDA database entry for Z-1199-2025
• FDA 510(k) clearance · K230866The device's official FDA premarket clearance record
• FDA device classification · DWJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Augustine Temperature Management, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.