Severity
Moderate
FDA Devices recall · Reported February 26, 2025
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 ma…
Augustine Temperature Management, LLC recalled Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF… - a moderate-severity action.
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF… was recalled by Augustine Temperature Management, LLC in February 26, 2025. Reason: There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It t…. Check the official notice for the remedy. Verify recall #Z-1198-2025 with the FDA Devices before acting.
The recall
Augustine Temperature Management, LLC issued this moderate-severity FDA Devices recall-There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It t….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1198-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1198-2025) was formally reported on February 26, 2025, with the manufacturer initiating the action on December 16, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Augustine Temperature Management, LLC is listed as the recalling firm, operating out of Minnetonka, MN. Federal records list the affected scope as 1 unit.
The documented reason for this recall is: 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 d… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of TX, AL, NV; AU, NZ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1 unit
Related Recalls
6
3 from same agency
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1198-2025 |
| Date reported | February 26, 2025 |
| Date initiated | December 16, 2024 |
| Recalling firm | Augustine Temperature Management, LLC |
| Firm location | Minnetonka, MN |
| Affected scope | 1 unit |
| Distribution | US Nationwide distribution in the states of TX, AL, NV; AU, NZ. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 26, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.