FDA Medical Device Recalls (openFDA)
Augustine Temperature Management, LLC: 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.
- Recall number
- Z-0700-2025
- Recalling firm
- Augustine Temperature Management, LLC
- 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.
- Status
- Open, Classified
- Initiated
- 2024-12-04
- Posted
- 2024-12-18
- Terminated
- not on file
- 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".
- Root cause
- Device Design
- Action
- Augustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. If the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. An optional power board update is available. For questions or concerns, contact: customercare@augsurg.com or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
- Quantity
- 135 units
- Distribution
- US and Canada
- Lot, serial or model codes
- 1) UDI-DI 00850011479018, Serial Numbers: 20080004-23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080004-23060141
- 510(k) numbers
- ["K201779","K220941"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 3005857264
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28