F&P Optiflow Junior 2 OJR418Recalls & 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
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 09420012435972), received between Oct 27, 2020 and Jun 24, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 Component14
- Break7
- Use of Device Problem2
- Device Handling Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Low Oxygen Saturation1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 4, 2026Break; Detachment of Device or Device Component
A DISTRIBUTOR IN MALAYSIA HAS REPORTED THAT THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS TORN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954372 ↗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 OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END AND FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774403 ↗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 AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774402 ↗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 AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA HAD DETACHED FROM THE CONNCETOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774364 ↗MalfunctionJun 19, 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 THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. THERE WAS NO FURTHER REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288765 ↗MalfunctionJun 17, 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 THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO CONTINUE THE PATIENT THERAPY. THERE WAS NO FURTHER REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22257011 ↗MalfunctionFeb 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN MISSOURI REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21440486 ↗MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED AT THE SWIVEL GRIP TUBE JOINT DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20803053 ↗MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN FRANCE REPORTED THAT THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED AT THE SWIVEL GRIP TUBE JOINT DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20803052 ↗MalfunctionSep 22, 2024Detachment 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) REPRESENTATIVE THAT THE OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA XL'S TUBING WAS DETACHED FROM THE CANNULA TUBE JOINT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20276225 ↗MalfunctionSep 13, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN SOUTH AFRICA ON BEHALF OF A HEALTHCARE FACILITY HAS REPORTED THAT AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA'S TUBING WAS BROKEN AT THE SWIVEL GRIP TUBE JOINT AFTER 16 HOURS OF PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20209285 ↗MalfunctionMar 17, 2022Break
A DISTRIBUTOR IN (B)(4) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS FOUND BROKEN BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13794890 ↗MalfunctionDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA BROKE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13011880 ↗MalfunctionFeb 16, 2021Use of Device Problem; Detachment of Device or Device Component; Break; Use of Device Problem; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF TWO OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULAS BROKE DURING USE. IT WAS NOTED THAT THE TUBING WAS POSSIBLY PULLED OR ACCIDENTALLY CAUGHT ON EQUIPMENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11336003 ↗MalfunctionFeb 16, 2021Use of Device Problem; Detachment of Device or Device Component; Break; Use of Device Problem; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN INDIANA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA BROKE AFTER TWO DAYS OF USE. IT WAS NOTED THAT THE TUBING WAS POSSIBLY PULLED OR ACCIDENTALLY CAUGHT ON EQUIPMENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11336002 ↗MalfunctionOct 27, 2020Device Handling Problem; Break; Device Handling Problem
A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT AN OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA BROKE AFTER 2 DAYS OF USE. IT WAS REPORTED THAT THE PATIENT DESATURATED. IT WAS NOTED THAT THE TUBING WAS LIKELY PULLED BY THE PATIENT. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 10742378 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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