F&P Optiflow Junior 2Recalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 241
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 16 models of F&P Optiflow Junior 2 by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 241 adverse event reports in the FDA's MAUDE database, received between May 20, 2020 and Sep 30, 2026 — classified as 241 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (171 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported F&P Optiflow Junior 2 problems
Device problems
- Detachment of Device or Device Component171
- Break72
- Material Split, Cut or Torn22
- Disconnection6
- Use of Device Problem6
- Loss of or Failure to Bond5
- Material Integrity Problem4
- Insufficient Device Problem Information3
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- Low Oxygen Saturation17
- No Known Impact Or Consequence To Patient4
- No Patient Involvement2
- No Consequences Or Impact To Patient1
F&P Optiflow Junior 2 models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- F&P Optiflow Junior 2 OJR412Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Optiflow Junior 2 OJR414Humidifier, Respiratory Gas, (Direct Patient Interface)56 reports
- F&P Optiflow Junior 2 OJR416Humidifier, Respiratory Gas, (Direct Patient Interface)37 reports
- F&P Optiflow Junior 2 OJR410Humidifier, Respiratory Gas, (Direct Patient Interface)18 reports
- F&P Optiflow Junior 2 OJR418Humidifier, Respiratory Gas, (Direct Patient Interface)17 reports
- F&P Optiflow Junior 2 OJR410VTHumidifier, Respiratory Gas, (Direct Patient Interface)5 reports
- F&P Optiflow Junior 2 OJR412VTHumidifier, Respiratory Gas, (Direct Patient Interface)5 reports
- F&P Optiflow Junior 2 OJR418HMHumidifier, Respiratory Gas, (Direct Patient Interface)5 reports
- F&P Optiflow Junior 2 OJR414VTHumidifier, Respiratory Gas, (Direct Patient Interface)4 reports
- F&P Optiflow Junior 2 OJR412BHumidifier, Respiratory Gas, (Direct Patient Interface)3 reports
- F&P Optiflow Junior 2 OJR414BHumidifier, Respiratory Gas, (Direct Patient Interface)3 reports
- F&P Optiflow Junior 2 OJR418VTHumidifier, Respiratory Gas, (Direct Patient Interface)2 reports
- F&P Optiflow Junior 2 OJR416BHumidifier, Respiratory Gas, (Direct Patient Interface)2 reports
- F&P Optiflow Junior 2 OJR416VTHumidifier, Respiratory Gas, (Direct Patient Interface)2 reports
- F&P Optiflow Junior 2 OJR410BHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
- F&P Optiflow Junior 2 OJR416HMHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
Recent F&P Optiflow Junior 2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 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 OJR412 Optiflow Junior 2 Nasal Cannula detached from cannula end during use.There was no reported patient consequence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941927 ↗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 18, 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 OJR412 Optiflow Junior 2 Nasal Cannula detached from cannula end during use. It was also reported that the cannula was replaced to maintain the therapy.There was no reported patient consequence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813946 ↗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 ↗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 ↗MalfunctionJun 24, 2026Detachment of Device or Device Component
A DISTRIBUTOR IN SOUTH AFRICA ON BEHALF OF A HEALTHCARE FACILITY HAS REPORTED THAT THE TUBING OF AN OJR418 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 25605587 ↗MalfunctionMay 26, 2026
OPTIFLOW JUNIOR NASAL CANNULA WAS IN-PLACE AND DELIVERING OXYGEN TO THE PATIENT. UPON PHYSICAL ASSESSMENT, IT WAS NOTED THAT THE SPRING TUBING HAD DETACHED FROM THE NOSE PIECE. THERE WAS NO PRIOR INTERACTION WITH THE NASAL CANNULA THAT WAS IDENTIFIED AS CAUSING THE DETACHMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25277195 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN SWITZERLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND TO BE DETACHED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155887 ↗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 ↗MalfunctionApr 22, 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 THE TUBING OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM CANNULA DURING USE. IT WAS FURTHER REPORTED THAT THE CAREGIVER PULLED ON THE CANNULA TUBING BEFORE PLACING IT ON THE PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24951777 ↗MalfunctionMar 31, 2026Detachment 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 THE TUBING OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA. IT WAS FURTHER REPORTED THAT THE PATIENT MAY HAVE PULLED THE CANNULA TUBING. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750471 ↗
Other Fisher & Paykel Healthcare Limited products
All Fisher & Paykel Healthcare Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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