F&P Optiflow Junior 2 OJR414BRecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior 2 Blender Transition Kit · Class 2
All models of F&P Optiflow Junior 2 (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09420012448873), received between Feb 17, 2021 and Jan 4, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2026Break
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPTIFLOW JUNIOR 2 NASAL CANNULA, AS PART OF THE OJR414B OPTIFLOW JUNIOR 2 BLENDER TRANSITION KIT M, WAS BROKEN DURING USE. IT WAS FURTHER REPORTED THAT TWO CANNULAS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954373 ↗MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN ZWOLLE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR412B OPTIFLOW JUNIOR 2 CANNULA BLENDER KIT WAS FOUND DETACHED AT THE CANNULA TUBE JOINT AFTER 5 DAYS OF USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20454916 ↗MalfunctionFeb 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE NASAL PRONGS DURING USE. IT WAS FURTHER REPORTED THAT THE PATIENT DESATURATED AND THE SUBJECT DEVICE WAS REPLACED. THERE WERE NO FURTHER PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation
MAUDE report 11341087 ↗
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- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Optiflow Junior 2 OJR414Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)56 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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