F&P Optiflow Junior 2 OJR412VTRecalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior 2 Ventilator Transition Kit · Class 2
All models of F&P Optiflow Junior 2 (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09420012448958), received between Jun 29, 2023 and Feb 4, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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
- Detachment of Device or Device Component4
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Oxygen Saturation2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Material Split, Cut or Torn
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE TUBING OF AN OJR412VT OPTIFLOW JUNIOR 2 NASAL CANNULA WAS TORN NEXT TO THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265019 ↗MalfunctionSep 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN AMSTERDAM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF THE OPTIFLOW JUNIOR 2 NASAL CANNULA, THAT COMES WITH THE OJR412VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KITS, WAS DETACHED FROM THE CANNULA. IT WAS FURTHER REPORTED THAT OTHER 4 UNITS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23140137 ↗MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE TUBING OF AN OJR412VT OPTIFLOW JUNIOR 2 NASAL CANNULA S VENTILATOR KIT HAD DETACHED AT THE CANNULA TUBE JOINT DURING USE ON A PATIENT USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT EXPERIENCED TEMPORARY DESATURATION. IT WAS FURTHER REPORTED THAT THE PATIENT BECAME ANXIOUS, GRABBED, AND PULLED THE TUBING WHICH RESULTED IN THE CANNULA TUBE DETACHMENT. THE SUBJECT CANNULA WAS REPLACED WITH ANOTHER CANNULA TO CONTINUE THE THERAPY. THERE WERE NO FURTHER CONSEQUENCES REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 21175315 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN ILLINOIS HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OJR412VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT S'S TUBING WAS DETACHED FROM THE CANNULA TUBE JOINT DURING PATIENT USE. A HEALTHCARE FACILITY FURTHER REPORTED THAT THERE ARE TWO CANNULAS EFFECTED DUE TO THE REPORTED FAILURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20413859 ↗MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CLERMONT-FERRAND, FRANCE REPORTED THAT THE TUBING OF AN OJR412VT OPTIFLOW JUNIOR 2 NASAL CANNULA S VENTILATOR KIT HAD DETACHED DURING USE. IT WAS ALSO REPORTED THAT THE PATIENT DESATURATED BRIEFLY. THE SUBJECT CANNULA WAS REMOVED AND REPLACED WITH ANOTHER CANNULA AND THE PATIENT RECOVERED TO A STABLE CONDITION. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 17233923 ↗
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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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