FDA Medical Device Recalls (openFDA)
Augustine Temperature Management, LLC: Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
- Recall number
- Z-1172-2025
- Recalling firm
- Augustine Temperature Management, LLC
- Product
- Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
- Status
- Open, Classified
- Initiated
- 2024-02-15
- Posted
- 2025-02-14
- Terminated
- not on file
- Reason
- Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
- Root cause
- Device Design
- Action
- Augustine Temperature Management contacted their consignees by visit beginning on 02/15/2024 to replace the affected cables. The firm collected email confirmation that the original cables had either been returned or destroyed. If you have any questions, contact the Product Manager at 952-465-3526 or email:
- Quantity
- 7 unit
- Distribution
- US distribution to states of: AL, TX, NV
- Lot, serial or model codes
- UDI-DI 00850011479674, Lot Number 2339
- 510(k) numbers
- ["K210727","K230866"]
- 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