FDA Medical Device Recalls (openFDA)
Augustine Temperature Management, LLC: Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
- Recall number
- Z-0841-2025
- Recalling firm
- Augustine Temperature Management, LLC
- Product
- Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
- Status
- Completed
- Initiated
- 2022-03-14
- Posted
- 2025-01-10
- Terminated
- not on file
- Reason
- 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
- 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
- 77 units
- Distribution
- Worldwide
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- 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