FDA Medical Device Recalls (openFDA)
Augustine Temperature Management, LLC: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
- Recall number
- Z-1197-2025
- Recalling firm
- Augustine Temperature Management, LLC
- Product
- Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
- Status
- Open, Classified
- Initiated
- 2024-12-16
- Posted
- 2025-02-20
- Terminated
- not on file
- Reason
- There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
- Root cause
- Device Design
- Action
- Augustine Temperature Management began notifying its consignees on 12/16/2024 via email and visit to exchange the affected product.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of TX, AL, NV; AU, NZ.
- Lot, serial or model codes
- UDI-DI UDI-DI 00855913001817, Serial Numbers: 1304292, 1304293, 1304296, 1304297
- 510(k) numbers
- ["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