Augustine Surgical Inc — Class II medical device recall Z-0701-2025
Ongoing recall by Augustine Temperature Management, LLC, reported 2024-12-25. Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Ma
| Recall number | Z-0701-2025 |
|---|---|
| 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 | 2024-12-04 |
| Classified | 2024-12-18 |
| Reported by FDA | 2024-12-25 |
| Countries outside the US | CA |
| Quantity | 1,776 units |
| UPC / GTIN / UDI-DI | 00850011479025, 00850011479292, 00850011479308 |
| Serial numbers | 20080060-24060065 |
| Model numbers | WC77, WC77D, WC77R |
Product
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Reason for recall
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".
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-0701-2025. 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.