Z-1172-2025Class II

Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction...

Name: Z-1172-2025 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction...
Creator: Augustine Temperature Management, LLC
Published: 2024-02-15
License: https://open.fda.gov/license/

Augustine Temperature Management, LLC / initiated 2024-02-15 / Open, Classified / root cause: design

FDA source

Augustine Temperature Management, LLC began a recall of Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses on 2024-02-15. FDA classified it as Class II and gives the reason as "Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1172-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-15
Posted: 2025-02-14
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
Root cause tag: design
FDA 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 in commerce: 7 unit
Distribution: US distribution to states of: AL, TX, NV
Product codes and lots: UDI-DI 00850011479674, Lot Number 2339

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1172-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1171-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-14
Z-1172-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-14

Product code DWJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)