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HUDSON RCI HUD1820Recalls & reported problems

Medline Industries, Inc. · O2 CANNULA,ADULT,SOFTECH,7' TUB,SC · 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 10197344009947), received between Aug 25, 2026 and Sep 8, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (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. How this data works · Data updated Oct 13, 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: 0 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: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Emits Odor1
  • Gas/Air Leak1
  • Loss of or Failure to Bond1
  • Material Deformation1

Patient problems

  • Headache1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 8, 2026Loss of or Failure to Bond; Gas/Air Leak; Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50671594 ↗
  • MalfunctionAug 25, 2026Device Emits Odor

    The report states, "The first cannula was tested, and we noticed an unbearable odor, not only from the plastic material of the cannula itself but also a mold-like smell. This caused the patient to develop a headache after using it for a couple of hours. This has never happened before with your cannulas. We then opened two additional cannulas and found the same issue. We tried airing them out by leaving them in open air, but the problem persists."

    Patient problems: Headache

    MAUDE report 50430287 ↗

Other CANNULA, NASAL, OXYGEN devices

All CANNULA, NASAL, OXYGEN devices →

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