Vital Signs™ M1024247Recalls & reported problems
AirLife Finland Oy · Reusable Temperature Probes, 400-Series, General Purpose Probe, Adult, 3 m/10 ft. · Class 2
All models of Vital Signs (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190752125643), received between Aug 4, 2022 and Aug 5, 2022 — classified as 2 injuries, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SATUROMETER (REUSABLE GEN PURPOSE TEMPERATURE PROBE) FAILED. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15179532 ↗InjuryAug 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ECG CABLE WAS MALFUNCTIONING. THERE WAS PATIENT INVOLVEMENT AND THE PATIENT WAS TRANSFERRED TO ANOTHER STATION WITHOUT ANY IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15170220 ↗InjuryAug 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ECG CABLE WAS MALFUNCTIONING. THERE WAS PATIENT INVOLVEMENT AND THE PATIENT WAS TRANSFERRED TO ANOTHER STATION WITHOUT ANY IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15169972 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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