Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, t...
FDA Device Recall #Z-1199-2025 — Class II — December 16, 2024
Recall Summary
| Recall Number | Z-1199-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 16, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Augustine Temperature Management, LLC |
| Location | Minnetonka, MN |
| Product Type | Devices |
| Quantity | 3 units |
Product Description
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, 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.
Distribution Pattern
US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
Lot / Code Information
UDI-DI UDI-DI 00855913001848, Serial Numbers: 1304384, 1304619, 1304620
Other Recalls from Augustine Temperature Management, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1198-2025 | Class II | Hot Dog PATIENT WARMING, Underbody Warming Matt... | Dec 16, 2024 |
| Z-1197-2025 | Class II | Hot Dog PATIENT WARMING, Underbody Warming Matt... | Dec 16, 2024 |
| Z-0701-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING... | Dec 4, 2024 |
| Z-0702-2025 | Class II | Hillrom Temperature Management Controller, MP, ... | Dec 4, 2024 |
| Z-0700-2025 | Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING... | Dec 4, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.