HUDSON RCI HUD00540Recalls & reported problems
Medline Industries, Inc. · KIT,HUMID,AQUAPAK,540ML,H2O, ADPT · Class 2
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20197344007155), received between Nov 19, 2024 and Sep 30, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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. 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
- Appropriate Device Problem Term/Code Not Available3
- Connection Problem1
- Failure to Cut1
- Fluid/Blood Leak1
Patient problems
- Hypoxia2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that "Customer had received 1EA leaked bottle despite no damage to the carton box."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945729 ↗InjuryFeb 24, 2026Failure to Cut
ACCORDING TO THE FACILITY, ON (B)(6) 2026, A PEDIATRIC RAPID RESPONSE WAS INITIATED AT 0430 DUE TO INCREASED OXYGEN NEEDS AND EXTREME LETHARGY IN THE PATIENT BEING HOSPITALIZED FOR RSV AND ACUTE RESPIRATORY FAILURE. THE ICU RN SUGGESTED TRYING A FACE MASK TO IMPROVE SATURATIONS. WHEN RT ARRIVED, IT WAS NOTED THAT THE O2 BUBBLER WAS NOT WORKING PROPERLY (INTERRUPTION OF OXYGEN BEING DELIVERED). A NEW BUBBLER WAS OBTAINED AND RESULTED IN IMPROVEMENT IN O2 STATUS. THE OXYGEN BUBBLER WAS FOUND TO NOT BE PUNCTURED, ALTHOUGH PIECES OF PLASTIC WERE BROKEN OFF APPROPRIATELY AND OXYGEN HAD BEEN CONNECTED APPROPRIATELY.
Patient problems: Low Oxygen Saturation
MAUDE report 24431736 ↗InjuryNov 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024, IT WAS DISCOVERED THAT THE BOTTLE WAS "NOT PUNCTURED DESPITE BEING PROPERLY SCREWED IN" CAUSING THE PATIENT ON AN AEROSOL MASK TO DESATURATE.
Patient problems: Hypoxia
MAUDE report 20762749 ↗InjuryNov 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE "HUMIDIFICATION BOTTLE WAS NOT ADEQUATELY PUNCTURED AND PATIENT WITH TRACHEOSTOMY DID NOT RECEIVE HUMIDIFICATION" CAUSING THE PATIENT "TO HAVE THICK SECRETIONS AND FREQUENT SUSTAINED DESATURATIONS".
Patient problems: Hypoxia
MAUDE report 20758592 ↗InjuryNov 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY, A TRACHED PATIENT REQUIRED HUMIDIFICATION VIA TRACH COLLAR/BUBBLE BOTTLE. A NEW HUDSON AQUAPAK BUBBLE BOTTLE WAS USED DURING SHIFT WITH MANY PROBLEMS.
Patient problems: Insufficient Information
MAUDE report 20757111 ↗MalfunctionNov 19, 2024Connection Problem; Connection Problem
ACCORDING TO THE FACILITY ON 06/08/2024 "PATIENT'S TRACH NOTED TO BE PLUGGED REQUIRING ADDITIONAL INTERVENTIONS TO RESOLVE".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20728825 ↗
Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices
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- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 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
- 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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