Recall archive / FDA device enforcement
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # W... — FDA record Z-0700-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
- Reason
- Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
- Classification
- Class II
- Recalling firm
- Augustine Temperature Management, LLC
- Quantity
- 135 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0700-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) UDI-DI 00850011479018, Serial Numbers: 20080004-23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080004-23060141 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US and Canada
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 25, 2024
- Recall initiation date
- Dec 4, 2024
- Center classification date
- Dec 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.