F&P Optiflow Junior 2 OJR410VTRecalls & 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 09420012448934), received between Sep 12, 2024 and Feb 4, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 Component5
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Low Oxygen Saturation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR410VT OPTIFLOW JUNIOR 2 NASAL INTERFACE VENTILATOR TRANSITION KIT, WAS DETACHED FROM THE CANNULA END DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261057 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
A HEALTHCARE FACILITY IN SWITZERLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPTIFLOW JUNIOR 2 NASAL CANNULA OF THE OJR410VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS DEFECTIVE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375133 ↗MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN LONDON REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING ON ONE SIDE OF AN OPTIFLOW JUNIOR 2 NASAL CANNULA OF THE OJR410VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS DETACHED. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE CANNULA WAS IMMEDIATELY REPLACED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22604523 ↗MalfunctionJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN UNITED KINGDOME REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR410VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS DETACHED DURING USE ON A PATIENT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED A MINOR DESATURATION, WHICH WAS EFFECTIVELY MANAGED THROUGH RESUSCITATION USING A NEOPUFF RESUSCITATOR. THE PATIENT WAS SUBSEQUENTLY STABILIZED, AND THE CANNULA WAS REPLACED. THERE WAS NO FURTHER REPORTED PATIENT CONSEQUENCE.
Patient problems: Low Oxygen Saturation
MAUDE report 22325361 ↗MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR410VT OPTIFLOW JUNIOR 2 VENTILATOR TRANSITION KIT WAS FOUND TO BE DISCONNECTED FROM THE WIGGLEPAD DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20208667 ↗
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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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