F&P Optiflow Junior 2 OJR416Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior Nasal Cannula · Class 2
All models of F&P Optiflow Junior 2 (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Fisher & Paykel Optiflow Junior2 nasal cannula, a breathing tube that delivers humidified oxygen to children. The 35 reports mostly describe parts coming loose or breaking apart during use — tubing detaching from the cannula end, swivels pulling off the connector, cracked or torn material, and holes that caused leaks — along with pads that would not stick. No deaths and no injuries are reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 09420012435958), received between Jul 17, 2020 and Sep 27, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 Component16
- Break15
- Material Split, Cut or Torn6
- Material Integrity Problem3
- Gas/Air Leak2
- Loss of or Failure to Bond2
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Low Oxygen Saturation1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2026Loss of or Failure to Bond; Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910484 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910424 ↗MalfunctionSep 25, 2026Gas/Air Leak
A healthcare facility in Finland reported that a leak was observed from the left side tubing of an OJR416 Optiflow Junior 2 Nasal Cannula after 2 days of patient use. There were no reported patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892920 ↗MalfunctionSep 17, 2026Material Split, Cut or Torn
A distributor in South Africa reported on behalf of a healthcare facility that the tubing of an OJR416 Optiflow Junior 2 Nasal cannula was pulled from the connector (swivel grip) end, with a portion of the tubing still attached to the connector. There was no reported patient consequence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797660 ↗MalfunctionApr 29, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN POLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25038452 ↗MalfunctionMar 19, 2026Break
A HEALTHCARE FACILITY IN ITALY REPORTED THAT THE OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS BROKEN. IT WAS ALSO REPORTED THAT THE CANNULA HAD BEEN CLEANED AND REPOSITIONED MULTIPLE TIMES DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635892 ↗MalfunctionFeb 24, 2026Material Perforation; Gas/Air Leak
A HEALTHCARE FACILITY IN POLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA DEVELOPED HOLES DURING USE, WHICH RESULTED IN LEAKS. IT WAS ALSO REPORTED THAT SALBUTAMOL INHALATIONS WERE USED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438065 ↗MalfunctionDec 18, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE WIGGLEPAD OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS NOT STICKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846920 ↗MalfunctionDec 18, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT TWO WIGGLEPADS OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WERE NOT STICKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846915 ↗MalfunctionNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN JAPAN ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND DETACHED FROM THE CANNULA END DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23613192 ↗MalfunctionNov 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23590026 ↗MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA. THERE WERE NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23527092 ↗MalfunctionNov 11, 2025Break; Break
A DISTRIBUTOR IN TAIWAN REPORTED THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23527089 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA ON BEHALF OF A HEALTHCARE FACILITY HAS REPORTED THAT THE TUBING OF OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CONNECTOR (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411920 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA HAS REPORTED THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CONNECTOR (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411782 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN BRAZIL ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA WHEN THE PATIENT PULLED ON THE TUBE. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23306543 ↗MalfunctionOct 9, 2025Material Puncture/Hole; Material Puncture/Hole
A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA HAD SMALL HOLES NEXT TO CONNECTOR END (SWIVEL GRIP). THERE WERE NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23262780 ↗MalfunctionSep 16, 2025Break; Break
A DISTRIBUTOR IN BRAZIL ON BEHALF OF THE PATIENT'S MOTHER REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416HM OPTIFLOW JUNIOR 2 NASAL CANNULA WAS BROKEN DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069519 ↗MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA DURING PATIENT USE. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED AND DISCARDED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22672926 ↗MalfunctionMay 28, 2025Break; Break
A DISTRIBUTOR IN BRAZIL ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT A PATIENT PULLED AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA FROM THEIR FACE IN AN ATTEMPT TO REMOVE IT. AS A RESULT, ONE OF THE TUBES DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101956 ↗MalfunctionMay 28, 2025Break; Break
A DISTRIBUTOR IN BRAZIL ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED DURING USE. THE DISTRIBUTOR HAS FURTHER REPORTED THAT THE PATIENT PULLED ON THE TUBE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101955 ↗MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA REPORTED THAT THE TUBING OF AN OJR416 OPTIFLOW JUNIOR 2 CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21298658 ↗MalfunctionFeb 3, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
A DISTRIBUTOR IN SOUTH AFRICA REPORTED THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 CANNULA WAS FOUND DAMAGED DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21290887 ↗MalfunctionDec 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DAMAGED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20959164 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OJR416 OPTIFLOW JUNIOR 2 NASAL CANNULA HAD BECOME LOOSE DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412783 ↗
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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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