Hot Dog PATIENT WARMING — Class II medical device recall Z-1197-2025
Ongoing recall by Augustine Temperature Management, LLC, reported 2025-02-26, distributed nationwide. There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It tur
| Recall number | Z-1197-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Augustine Temperature Management, LLC, Minnetonka, MN, United States |
| Recall initiated | 2024-12-16 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00855913001817 |
| Serial numbers | 1304292, 1304293, 1304296, 1304297 |
| Model numbers | US501 |
Product
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1197-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.