Kozee M21505Recalls & reported problems
Sourcemark, LLC. · Warming Unit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08973920006730), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “No Audible Prompt/Feedback” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- No Audible Prompt/Feedback1
- Output Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2025No Audible Prompt/Feedback; Output Problem; No Audible Prompt/Feedback; Output Problem
A PATIENT WENT UNDER A 6HR HEART SURGERY. THE HOSPITAL USED 505 BLOWER WITHOUT BLANKET. THE PATIENT EXPERIENCED A SECOND DEGREE BURN ON BOTH LEGS. THE HOSPITAL IS CLAIMING THAT OUR EQUIPMENT DID NOT HAVE ALARM OR AUTOMATICALLY STOP WHEN OVERHEATING. THE HOSPITAL'S BIOMED GROUP DID A TEST SHOWING THAT OUR BLOWER CONTINUED BLOWING EVEN WHEN THE TEMPERATURE AT THE AIR HOSE HITTING 63 DEGREES.
Patient problems: Burn(s)
MAUDE report 22902938 ↗
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- HotDog Temperature Management System WC77Augustine Temperature Management LLC · System, Thermal Regulating2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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