HUDSON RCI HUDRHP340URecalls & reported problems
Medline Industries, Inc. · KIT,WATER,STERILE,AQUAPAK,340ML W/ADAPT · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20193489139683), received between Jun 19, 2026 and Sep 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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
- Fluid/Blood Leak3
- Component Missing2
- Backflow1
- Damaged Thread1
- Fitting Problem1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Component Missing
It was reported that customer was unpacking a case of this item and noticed that 9 were sent without adaptor. The bag that the item was wrapped in was sealed and intact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945991 ↗MalfunctionSep 29, 2026Backflow; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936805 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Noise, Audible; Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922288 ↗MalfunctionSep 18, 2026Fitting Problem
This summary report covers malfunction events that occurred between January 1 and March 31, 2024. This VMSR summarizes one malfunction event involving Medline AquaPak 340 mL pre-filled humidifier bottles (catalog number HUDRHP340U). The account reported that the tubing connector was too small to permit effective flow and that the orifice had to be enlarged for effective performance. The physical device was not returned; review of the photographs did not confirm the reported malfunction. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817657 ↗MalfunctionSep 17, 2026Component Missing
It was reported that ¿they did not receive the adapters that go with item #: HUDRHP340U.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802117 ↗MalfunctionJun 19, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE BOTTLES LEAKED WATER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563737 ↗
Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
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- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- 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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