F&P Optiflow Junior 2 OJR410Recalls & 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 09420012435743), received between Nov 7, 2022 and Apr 22, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 Component13
- Break6
- Insufficient Device Problem Information1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Low Oxygen Saturation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionFeb 26, 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 OJR410 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 24451092 ↗MalfunctionFeb 4, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN BRAZIL REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR410 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 24260144 ↗MalfunctionDec 10, 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 OJR410 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 23774365 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FINLAND 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 END DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23711922 ↗MalfunctionNov 16, 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 OJR410 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 23565704 ↗MalfunctionNov 3, 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 TWO OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULAS DETACHED FROM THE CANNULA DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459476 ↗MalfunctionOct 29, 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 OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND DETACHED FROM THE CONNECTOR (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420791 ↗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 OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THE HEALTHCARE FACILITY ALSO REPORTED THAT THE CANNULA IS NOT AVAILABLE FOR EVALUATION. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297804 ↗MalfunctionOct 6, 2025Break; Break
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 OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS TORN NEXT TO THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23230521 ↗MalfunctionSep 11, 2025Break; Detachment of Device or Device Component; Break; 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 OJR410 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 23033589 ↗MalfunctionAug 4, 2025Break; Detachment of Device or Device Component; Break; 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 ONE OF THE TUBING OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND DETACHED DURING USE ON PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708009 ↗MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED THAT THE TUBING OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA TUBE JOINT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22248281 ↗MalfunctionJan 30, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND TO BE FAULTY DURING USE ON PATIENT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT EXPERIENCED MINOR DESATURATION AND ASSOCIATED BRADYCARDIA. FISHER AND PAYKEL HEALTHCARE IS CURRENTLY GATHERING FURTHER INFORMATION RELATED TO THE REPORTED EVENT AND PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation
MAUDE report 21277937 ↗MalfunctionOct 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE CANNULA OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND DAMAGED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20355961 ↗MalfunctionJan 31, 2023Break; Break
A DISTRIBUTOR IN JAPAN ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA TUBE JOINT DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16273921 ↗MalfunctionNov 7, 2022Break; Break
A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR410 OPTIFLOW JUNIOR 2 NASAL CANNULAS WERE DETACHED FROM THE CANNULA DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749878 ↗
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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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