F&P Optiflow Junior 2 OJR414Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior 2 Nasal cannula · Class 2
All models of F&P Optiflow Junior 2 (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Fisher & Paykel Optiflow Junior 2 nasal cannula, a breathing tube that delivers humidified oxygen to children. The 53 reports mostly describe the tubing coming loose or detaching from the connector or cannula end, along with cracking, splitting or tearing of the material. No deaths and no injuries were reported, and few reports mention any effect on the patient, such as low oxygen levels. 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 09420012435934), received between May 20, 2020 and Jul 6, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (37 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 Component37
- Break18
- Material Split, Cut or Torn7
- Disconnection2
- Loss of or Failure to Bond2
- Use of Device Problem2
- Material Separation1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- No Known Impact Or Consequence To Patient4
- Low Oxygen Saturation3
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN ILLINOIS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727734 ↗MalfunctionJul 2, 2026Detachment 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 UPON OPENING THE PACKAGING, THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND TO BE DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25686761 ↗MalfunctionJul 1, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FRANCE REPORTED THE THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA END. IT WAS ALSO REPORTED THAT THE NURSE REMOVED THE CANNULA FROM THE PATIENT'S FACE BY PULLING ON IT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO MAINTAIN THE THERAPY WITH NO REPORTED CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682692 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684023 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN LAHTI REPORTED VIA FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED DURING USE. IT WAS FURTHER REPORTED THAT THERE ARE THREE AFFECTED UNITS. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553176 ↗MalfunctionMar 6, 2026Detachment 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 OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THE DISTRIBUTOR FURTHER REPORTED THAT THE NURSE PULLED ON THE CANNULA TUBING PRIOR TO POSITIONING IT ON THE PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528645 ↗MalfunctionFeb 17, 2026Detachment 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 A OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24373223 ↗MalfunctionFeb 9, 2026Detachment 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 A OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300546 ↗MalfunctionJan 15, 2026Detachment 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 OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24090264 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23969894 ↗MalfunctionJan 4, 2026Break
A HEALTHCARE FACILITY IN CANADA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS BROKEN DURING USE. IT WAS FURTHER REPORTED THAT FOUR OTHER CANNULAS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954371 ↗MalfunctionDec 17, 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 OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835202 ↗MalfunctionDec 10, 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 TWO OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774361 ↗MalfunctionDec 8, 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 OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752270 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN THAILAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF TWO OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULAS WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421075 ↗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 REPORTED THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND DETACHED AT THE CONNECTOR (SWIVEL GRIP) DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420790 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA REPORTED THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23411017 ↗MalfunctionOct 23, 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 OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP) DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376046 ↗MalfunctionOct 15, 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 OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23296747 ↗MalfunctionSep 25, 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 WIGGLEPADS OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA HAS COME OFF THE PRONGS BEFORE USE ON A PATIENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23151181 ↗MalfunctionSep 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS BROKEN DURING USE. IT WAS ALSO REPORTED BY THE HEALTHCARE FACILITY THAT IT IS LIKELY THAT THE CANNULA WAS PULLED OFF BY THE PATIENT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT WAS RECEIVING 40% OXYGEN AT THE TIME AND EXPERIENCED A DROP IN OXYGEN SATURATION. THERE WAS NO FURTHER REPORTED PATIENT CONSEQUENCE.
Patient problems: Low Oxygen Saturation
MAUDE report 23129957 ↗MalfunctionSep 16, 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 & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A PATIENT PULLED AN OJR414 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 23069521 ↗MalfunctionMay 25, 2025Stretched; Detachment of Device or Device Component; Material Split, Cut or Torn; Stretched; Detachment of Device or Device Component; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN NEW ZEALAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT ONE OF THE TUBING'S OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED AND THE OTHER ONE WAS COLLAPSED DURING USE ON A PATIENT THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT EXPERIENCED MINOR DESATURATION BUT WAS RECOVERED TO A STABLE CONDITION UPON REPLACING THE CANNULA. THERE WERE NO REPORTED FURTHER PATIENT CONSEQUENCES, AND THE PATIENT WAS DISCHARGED.
Patient problems: Low Oxygen Saturation
MAUDE report 22082926 ↗MalfunctionMar 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OJR414 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND DETACHED AT THE SWIVEL GRIP TUBE JOINT DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21674515 ↗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 21298437 ↗
Other Humidifier, Respiratory Gas, (Direct Patient Interface) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- 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 Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 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.
How reports and recalls are matched · Editorial policy · Report an error on this page