Vital Signs™ 3590Recalls & reported problems
Vyaire Medical, Inc. · Vital Signs™ Oral Airway Guedel · Class 1
Data updated Oct 18, 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 10190752131620), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
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.
InjurySep 30, 2020Contamination; Contamination
THE CUSTOMER REPORTED THAT THE SMALL, YELLOW PIECE OF PLASTIC ON 3590 VITAL SIGNS¿ ORAL AIRWAY SLID OUT OF THE ORAL AIRWAY INTO PATIENT'S PHARYNX DURING INTUBATION. THE CUSTOMER CONFIRMED THAT IT WAS REMOVED WITH HAGIL FORCEPS PRIOR TO CASE START PREVENTING HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10608514 ↗
Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices
- Air-Q3® 50005Airlife · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- King LTS-D KLTSD420King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300015PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- KING LTS-D Kit KLTSD430King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- Medline DYND300040PMedline Industries, Inc. · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- King LTS-D KLTSD421King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 reports
- ONE-PIECE GUEDEL AIRWAY, SIZE 3, ISO 9 1113090Intersurgical Incorporated · Airway, Oropharyngeal, Anesthesiology1 recall0 reports
- KING LTS-D Kit KLTSD432King Systems Corporation · AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page