HUDSON RCI HUDRHO41URecalls & reported problems
Medline Industries, Inc. · MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC · Class 1
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10197344010646), received between Dec 1, 2025 and Sep 29, 2026 — classified as 1 injury, 26 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Nov 21, 2025Class IIOpen, Classified
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Z-1035-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component17
- Loose or Intermittent Connection12
- Connection Problem3
- Disconnection2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Low Oxygen Saturation2
- Hypoxia1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Disconnection; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940251 ↗MalfunctionSep 29, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937476 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933371 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
It was reported that "THE TUBE THAT CONNECTS TO THE MASK IS COMING DISCONNECTED DURING CASES AND TRANSPORT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933362 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
It was reported that "Tubing is loose and is not staying connected to the mask."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916818 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916767 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916755 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823784 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723356 ↗MalfunctionSep 9, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697400 ↗MalfunctionSep 8, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675258 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674198 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569122 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568831 ↗MalfunctionSep 2, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
It was reported that, "The tubing is loose and comes off the mask easily."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566513 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565384 ↗MalfunctionSep 2, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565371 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564726 ↗MalfunctionSep 2, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564657 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548767 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548168 ↗MalfunctionSep 1, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547467 ↗MalfunctionSep 1, 2026Disconnection; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544540 ↗MalfunctionAug 27, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
It was reported that The 7 ft oxygen tubing fell off of the connector of the mask on 5 different masks today. The connection feels very loose and it is very easy for the oxygen tubing to fall away and thereby not deliver any oxygen to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483127 ↗MalfunctionDec 2, 2025Connection Problem; Connection Problem
ACCORDING TO THE FACILITY, THEY ARE HAVING ISSUES WITH THE TUBING DISCONNECTING FROM THE MASKS AFTER THEY COME OUT OF SURGERY INTO THE PACU SETTING.
Patient problems: Low Oxygen Saturation
MAUDE report 23696414 ↗
Other MASK, OXYGEN devices
- HUDSON RCI HUD1930Medline Industries, Inc. · MASK, OXYGEN1 recall12 reports
- Mask, Adult Aerosol, Vented 0250Westmed, Inc. · Mask, Oxygen8 reports
- AcuCare 60788Resmed Pty Ltd · Mask, Oxygen4 reports
- F&P FlexiTrunk BC801-10Fisher & Paykel Healthcare Limited · Mask, Oxygen4 reports
- Disposable Face Mask 000252956Ambu A/S · MASK, OXYGEN4 reports
- HUDSON RCI HUD1007Medline Industries, Inc. · MASK, OXYGEN4 reports
- F&P FlexiTrunk BC802-10Fisher & Paykel Healthcare Limited · Mask, Oxygen2 reports
- AcuCare 60786Resmed Pty Ltd · Mask, Oxygen2 reports
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 · each recall links to the FDA recall notice
- 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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