Agency classClass IIOur severity:High FDA (Devices)·Z-0839-2025·Announced 2025-01-22

Augustine Surgical temperature management controllers may experience power-on self-test error

Augustine Surgical temperature management controllers (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code. Seventeen units have been recalled worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device for patient temperature management. The reported power-on self-test error indicates potential device malfunction. No injuries or illnesses are reported. As a Class II device with potential failure but no documented harm, it meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Augustine Surgical Inc. has recalled temperature management controllers, Models WC71, WC77, and MP Model 2083516. These devices are used with warming blankets and mattresses to manage patient body temperature. Seventeen units have been recalled and distributed worldwide.

The affected controllers may experience a power-on self-test error code labeled 'EA POST' when powered on. This error may indicate a device malfunction. No details regarding clinical consequences or recommended user actions are provided in the source.

The recalled product

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.
Manufacturer: Augustine Temperature Management, LLC
Category: Medical Device — Patient Warming
Hazard: device-malfunction
self-test-error
Affected units: 17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

1) UDI-DI 00850011479018
Serial Numbers: 23060144
22030085
22030087
22030088
23060138
23060139
22030075
22030076
22030077
22030079
22030080
22030081
22030082
22030083
22030084
23060141
2) UDI-DI 00850011479285
Serial Numbers: 20080002

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Augustine Temperature Management, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Augustine Temperature Management, LLC

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