Z-0841-2025Class II

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and...

Name: Z-0841-2025 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and...
Creator: Augustine Temperature Management, LLC
Published: 2022-03-14
License: https://open.fda.gov/license/

Augustine Temperature Management, LLC / initiated 2022-03-14 / Completed / root cause: design

FDA source

Augustine Temperature Management, LLC began a recall of Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses on 2022-03-14. FDA classified it as Class II and gives the reason as "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"". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0841-2025
Classification: Class II
Status: Completed
Initiated: 2022-03-14
Posted: 2025-01-10
Recalling firm: Augustine Temperature Management, LLC
Product: Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Product code: DWJ System, Thermal Regulating
Reason for recall: 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".
Root cause tag: design
FDA root cause: Device Design
Action: Augustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.
Quantity in commerce: 77 units
Distribution: Worldwide
Product codes and lots: UDI-DI 00850011479582, Serial Numbers: 23010166, 23010167, 23010168, 23010169, 23010170, 23010171, 23010172, 23010173, 23010174, 23010175, 23010176, 23010177, 23010178, 23010179, 23010180, 23010181, 23010182, 23010183, 23010184, 23010185, 24020001, 24020002, 24020003, 24020004, 24020005, 24020006, 24030001, 24030002, 24030003, 24030004, 24030005, 24030021, 24030022, 24030023, 24030024, 24030025, 24030026, 24030027, 24030028, 24030029, 24030030, 24030016, 24030017, 24030018, 24030019, 24030020, 22120033, 24030011, 24030012, 24030013, 24030014, 24030015, 24030006, 24030007, 24030008, 24030009, 24030010, 24060001, 24060002, 24060003, 24060004, 24060005, 24060006, 24060007, 24060008, 24060009, 24060010, 24060024, 24060025, 24060026, 24060027, 24060028, 24060011, 24060012, 24060013, 24060014, 24060015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0841-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0839-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0840-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0841-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0842-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-10
Z-0843-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code DWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)