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Air-Q3® 60505Recalls & reported problems

Airlife · Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 5.0 · Class 1

All models of Air-Q3 (2)

Data updated Oct 16, 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 10889483480731), received between Mar 19, 2025 and Mar 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Slipped1
  • Failure to Seal1

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.

  • MalfunctionMar 19, 2025Device Slipped; Failure to Seal; Device Slipped; Failure to Seal

    IT WAS REPORTED, THE PROVIDER INSERTED THE AIRWAY DEVICE AND SECURED [IT] AS INSTRUCTED; FOUND AIRWAY DEVICE TO HAVE TWISTED OUT OF THE SECUREMENT DEVICE AND LOST SEAL. THE SEAL WAS CONFIRMED BY END TIDAL CARBON DIOXIDE (ETCO2) READINGS THAT WERE BOUNCING AROUND DURING TRANSPORT. UPON TRANSFER TO THE HOSPITAL STAFF, NO SEAL FROM THE DEVICE WAS FOUND. IT WAS ADDITIONALLY REPORTED, THE AIR-Q SP3G WAS TWISTING AND SLIPPED OUT OF THE THOMAS SELECT TUBE HOLDER. THIS CAUSED A LOSS OF SEAL IN THE AIRWAY DURING TRANSPORT. THERE WAS NO REPORTED INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21647806 ↗

Other Airway, Oropharyngeal, Anesthesiology devices

All Airway, Oropharyngeal, Anesthesiology devices →

Sources and updates

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