Vyaire 36-ML3500 MK8-STKRecalls & reported problems
Jaeger Medical GmbH · MicroLab · Class 2
All models of Vyaire (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 54250892905551), received between Nov 14, 2020 and Nov 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical Shorting” (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 18, 2026.
Most reported problems
Device problems
- Electrical Shorting1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2020Electrical Shorting; Electrical Shorting
IT IS REPORTED TO VYAIRE MEDICAL THAT THE MICROLAB SPIROMETER EXPERIENCED A BURNT PC BOARD AND A NON-FUNCTIONING LCD. THERE WAS NO PATIENT INVOLVED WITH THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10841313 ↗
Other Spirometer, Diagnostic devices
- Vmax 773835-101Carefusion Corporation · Spirometer, Diagnostic2 reports
- Welch Allyn, Inc. 901047Welch Allyn, Inc. · SPIROMETER, DIAGNOSTIC1 report
- Welch Allyn, Inc. 901128Welch Allyn, Inc. · SPIROMETER, DIAGNOSTIC1 report
- Vmax 773835-103Carefusion Corporation · Spirometer, Diagnostic1 report
- Vyaire 36-ML3535 MK8-STKJaeger Medical GmbH · Spirometer, Diagnostic1 report
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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