F&P Optiflow Junior 2 OJR412BRecalls & 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 09420012448859), received between Nov 2, 2021 and Aug 12, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
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.
MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN JAPAN REPORTED, ON BEHALF OF A HEALTHCARE FACILITY, THAT THE TUBING OF AN OPTIFLOW JUNIOR 2 NASAL CANNULA, AS PART OF THE OJR412B OPTIFLOW JUNIOR 2 NASAL INTERFACE BLENDER TRANSITION KIT S, WAS DETACHED FROM THE CANNULA. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT EXPERIENCED A MINOR OXYGEN DESATURATION, WITH THE LOWEST RECORDED LEVEL AROUND 90% SPO2. THE CANNULA WAS SUBSEQUENTLY REPLACED TO MAINTAIN THERAPY, AFTER WHICH THE PATIENT CONDITION PROMPTLY STABILISED. THERE WERE NO FURTHER REPORTED PATIENT CONSEQUENCES, AND THE PATIENT HAS SINCE BEEN DISCHARGED FROM HOSPITAL.
Patient problems: Low Oxygen Saturation
MAUDE report 22787576 ↗MalfunctionSep 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR412B OPTIFLOW JUNIOR 2 BLENDER TRANSITION KIT HAD DETACHED FROM THE CANNULA TUBE JOINT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15353964 ↗MalfunctionNov 2, 2021Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR412B OPTIFLOW JUNIOR 2 NASAL CANNULA HAD DETACHED FROM THE SWIVEL GRIP TUBE JOINT. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12741646 ↗
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- 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 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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