F&P Optiflow Junior 2 OJR412Recalls & 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 Fisher & Paykel Optiflow Junior 2 nasal cannula delivers oxygen. Reports mostly describe the tubing detaching from the nose piece or connector during use or unpacking, sometimes with low oxygen saturation. There are 78 reports, no deaths, and no injuries. No recalls name 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
- 80
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 09420012435910), received between May 26, 2020 and Sep 30, 2026 — classified as 80 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (63 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 Component63
- Break23
- Disconnection4
- Material Split, Cut or Torn4
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Loss of or Failure to Bond1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Low Oxygen Saturation6
Recent adverse event reports
The 25 most recent of 80 reports, 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 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 ↗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 ↗MalfunctionMar 24, 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 WHILE BEING REMOVED FROM THE PACKAGING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671767 ↗MalfunctionMar 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 AN OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24622435 ↗MalfunctionMar 13, 2026Detachment 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 OJR412 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 24596753 ↗MalfunctionMar 13, 2026Detachment 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587749 ↗MalfunctionFeb 27, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA END. IT WAS ALSO REPORTED THAT THE HOSPITAL STAFF MAY HAVE PULLED ON THE TUBING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466048 ↗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. IT WAS FURTHER REPROTED THAT TWO CANNULAS WERE EFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451094 ↗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 OJR412 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 24451088 ↗MalfunctionFeb 18, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA S WAS DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384455 ↗MalfunctionFeb 17, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OJR412 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 24373730 ↗MalfunctionFeb 4, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN JAPAN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF TWO OJR412 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 24261056 ↗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 A OJR412 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 24090265 ↗MalfunctionJan 7, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP) DURING USE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT EXPERIENCED AN INCREASED RESPIRATORY RATE. DURING ASSESSMENT, WHILE OXYGEN WAS BEING INCREASED AND THE PATIENT REPOSITIONED, THE NASAL CANNULA WAS FOUND DAMAGED. FOLLOWING REPLACEMENT OF THE CANNULA, THE PATIENT STABILIZED WITHOUT FURTHER CONSEQUENCES REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 23987725 ↗MalfunctionJan 5, 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, WHILE THE PATIENT WAS CRYING AND MOVING, THE PATIENT'S HAND HIT THE OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA, CAUSING THE TUBING TO DETACH FROM THE CANNULA END. THE DEVICE WAS REPLACED AND NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23968587 ↗MalfunctionDec 18, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846927 ↗MalfunctionDec 18, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DETACHED FROM THE CANNULA END DURING USE, WHICH ACTIVATED THE DESATURATION ALARM. IT WAS FURTHER REPORTED THAT THE PATIENT'S OXYGEN SATURATION TEMPORARILY DROPPED TO APPROXIMATELY 60%, BUT RETURNED TO NORMAL AFTER REPLACING THE CANNULA. THERE WAS NO FURTHER PATIENT CONSEQUENCES REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 23846027 ↗MalfunctionDec 17, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA END DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835526 ↗MalfunctionDec 17, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA END DURING USE. IT WAS REPROTED THAT TWO UNITS WERE AFFECTED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835524 ↗MalfunctionDec 17, 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 OJR412 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 23835201 ↗MalfunctionDec 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824202 ↗MalfunctionDec 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824201 ↗MalfunctionDec 15, 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 OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA DETACHED FROM THE CANNULA DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809605 ↗
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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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