HUDSON RCI HUD1930Recalls & reported problems
Medline Industries, Inc. · O2 MASK,MED CONC,ADULT,7' TUB UC · 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
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10197344009626), received between Aug 26, 2026 and Sep 30, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 Component7
- Disconnection4
- Loose or Intermittent Connection3
- Material Deformation1
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Low Oxygen Saturation2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948549 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932543 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: Low Oxygen Saturation
MAUDE report 50931395 ↗MalfunctionSep 28, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916337 ↗MalfunctionSep 22, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
It was reported that "Multiple recovery cases on 10/27 came out with simple mask flow tubing not connected to mask due to poor product securement. The lot #(10) 25FOA650 is the product failure with the flow tubing easily becoming disconnected from the mask."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858986 ↗MalfunctionSep 9, 2026Disconnection; Detachment of Device or Device Component
It was reported that ¿The tubing is very easily disconnecting from the mask, leaving the patient without oxygen and making them re-breathe CO2.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692207 ↗MalfunctionAug 28, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503769 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502863 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50501854 ↗MalfunctionAug 28, 2026Disconnection
It was reported that "tubing to the mask was disconnected. Very loose fitting. Tubing that connects to base of mask came dislodged."
Patient problems: Low Oxygen Saturation
MAUDE report 50498303 ↗MalfunctionAug 26, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462841 ↗MalfunctionAug 26, 2026Material Deformation; Material Too Soft/Flexible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455789 ↗
Other MASK, OXYGEN devices
- HUDSON RCI HUDRHO41UMedline Industries, Inc. · MASK, OXYGEN1 recall27 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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