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INOmax 91346Recalls & reported problems

Mallinckrodt Manufacturing LLC · One-Way Valve, 22F X 22M · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 8, 2023Open, Classified

    The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

    Z-2450-2023 · Root cause: Under Investigation by firm · FDA record ↗

Other Set, Tubing And Support, Ventilator (W Harness) devices

All Set, Tubing And Support, Ventilator (W Harness) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.