Facility

Augustine Temperature Management, LLC

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

3inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005857264
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	15305 Minnetonka Blvd Minnetonka, MN, US 55345
Registration status	Active · expires 2026
Parent company	Augustine Temperature Management, LLC (owner-operator 9076948)
Brand names	Hot Dog Patient Warming System

Activity by year

Recalls (4)
Inspections (3)
Warning letters (1)

Devices registered here (1)

System, Thermal Regulating
Product code DWJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5900

Recalls & enforcement

Class IIOngoing2024-12-16
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 ca…
Class IIOngoing2024-12-04
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".
Class IIOngoing2024-02-15
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Class IICompleted2022-03-14
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

FDA inspections (3)

OAI2024-11-27
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2023-09-19
Official Action Indicated · Compliance: Devices · citations posted
VAI2017-01-04
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2024-03-21
Warning Letter (opens in a new tab) · Minnetonka Minnesota

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Augustine Temperature Management, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Augustine Temperature Management, LLC (FEI 3005857264) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005857264-augustine-temperature-management-llc/

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