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Halyard 35118Recalls & reported problems

Avanos Medical, Inc. · ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 6.5MM · Class 2

All models of Halyard (232)

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 10680651351187), received between Nov 3, 2021 and Nov 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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.

Most reported problems

Device problems

  • Inflation Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 3, 2021Inflation Problem; Inflation Problem

    IT WAS REPORTED THAT "ON THE 7TH DAY AFTER PLACING THE TUBE, THE AUTO CUFF CONTROLLER DID NOT WORK AND COULD NOT APPLY PRESSURE TO THE CUFF. AFTER REPLACING THE TUBE, THERE WAS NO PROBLEM."

    Patient problems: Insufficient Information

    MAUDE report 12746872 ↗

Other Tube, Tracheal (W/Wo Connector) devices

All Tube, Tracheal (W/Wo Connector) devices →

Sources and updates

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