HUDSON RCI HUD1060Recalls & reported problems
Medline Industries, Inc. · MASK,OXY,NONREBREATHING,ADLT,7',SC · Class 1
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10197344011476), received between Sep 1, 2026 and Sep 21, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Infusion or Flow Problem1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hypoxia1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847030 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
It was reported that "We are finding that our HUD1060 oxygen masks under Lot# (10)25COA569 are not functioning correctly. The female connector for Oxygen tubing running into the mask is disconnecting with little to no manipulation by hand, and when used during a code was disconnecting only from the oxygen running through the line."
Patient problems: Hypoxia
MAUDE report 50753226 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573109 ↗MalfunctionSep 2, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564795 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549560 ↗
Other MASK, OXYGEN, NON-REBREATHING devices
- HUDSON RCI HUD1059Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING3 reports
- n/a 8130-7Salter Labs · MASK, OXYGEN, NON-REBREATHING2 reports
- HUDSON RCI HUD1936Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING1 report
- n/a SO-298-0Salter Labs · MASK, OXYGEN, NON-REBREATHING1 report
- n/a SO-430-0Salter Labs · MASK, OXYGEN, NON-REBREATHING1 report
- n/a 8140-7Salter Labs · MASK, OXYGEN, NON-REBREATHING1 report
- AirLife™ 001203Vyaire Medical, Inc. · MASK, OXYGEN, NON-REBREATHING1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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