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n/a 8130-7Recalls & reported problems

Salter Labs · Oxygen Mask (Adult) High concentration non-rebreather, with safety vent, 7’ (2.1 m) supply tube, Elastic strap fixation. · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607411800412), received between Jan 20, 2023 and Jan 27, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (2 reports).

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.

Most reported problems

Device problems

  • Failure to Seal2

Patient problems

  • Respiratory Insufficiency2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 27, 2023Failure to Seal; Failure to Seal

    BAG BECAME SEPARATED FROM THE MASK.

    Patient problems: Respiratory Insufficiency

    MAUDE report 16256565 ↗
  • MalfunctionJan 20, 2023Failure to Seal; Failure to Seal

    ADHESIVE ON MASK NOT SECURED PROPERLY.

    Patient problems: Respiratory Insufficiency

    MAUDE report 16216434 ↗

Other MASK, OXYGEN, NON-REBREATHING devices

All MASK, OXYGEN, NON-REBREATHING devices →

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