Fisher and Paykel Healthcare OPT316Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior Infant Nasal Cannula · Class 2
All models of Fisher and Paykel Healthcare (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The Fisher & Paykel Optiflow Junior Infant Nasal Cannula is a nasal cannula that delivers breathing gas and moisture to infants. The reports mostly describe the tubing breaking, pulling away from the connector, tearing or splitting, and leaking air, sometimes leaving the patient without enough oxygen. There are 32 adverse event reports, with no deaths and no injuries, and 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 09420012432292), received between Jul 27, 2022 and May 20, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
- Break15
- Detachment of Device or Device Component14
- Material Split, Cut or Torn5
- Gas/Air Leak2
- Contamination /Decontamination Problem1
- Fracture1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information2
- Low Oxygen Saturation2
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Break
A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS FOUND TO BE BROKEN DURING USE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS RECEIVING AN INCREASED OXYGEN FLOW BEFORE THE DEFECTIVE DEVICE WAS REPLACED. THERE WAS NO FURTHER PATIENT CONSEQUENCE REPORTED.
Patient problems: Low Oxygen Saturation
MAUDE report 25237318 ↗MalfunctionJan 26, 2026Gas/Air Leak; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS LEAKING AIR DURING USE. IT WAS FURTHER REPORTED THAT THE TUBING OF THE NASAL CANNULA WAS DAMAGED AT THE CONNECTOR (SWIVEL GRIP) END. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24186128 ↗MalfunctionJan 19, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED VIA MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR 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 24112296 ↗MalfunctionJan 14, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN ROTTERDAM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE PATIENT DID NOT RECEIVE SUFFICIENT BREATHING. THE CANNULA WAS REPLACED TO CONTINUE THE THERAPY WITH NO REPORTED FURHTER CONSEQUENCES. F&P HAS REQUESTED FURTHER INFORMATION RELATED TO THE REPORTED EVENT.
Patient problems: Insufficient Information; Low Oxygen Saturation
MAUDE report 24064472 ↗MalfunctionSep 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
A DISTRIBUTOR IN CHINA REPORTED THAT THE WIGGLEPAD USED WITH THE OPTIFLOW JUNIOR NASAL CANNULA WOULD NOT ADHERE ON PATIENTS FACE. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23129863 ↗MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP) DURING USE ON A PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974927 ↗MalfunctionAug 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF OPT316 OPTIFLOW JUNIOR NASAL CANULA WAS TORN AT THE CONNECTOR END (SWIVEL GRIP). THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901394 ↗MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE INTERFACE DURING USE ON A PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22539027 ↗MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS DETACHED FROM THE SWIVEL GRIP TUBE JOINT BEFORE USE ON A PATIENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201091 ↗MalfunctionJun 4, 2025Break; Gas/Air Leak; Break; Gas/Air Leak
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS LEAKING DURING USE ON A PATIENT. THE HEALTHCARE FACILITY FURTHER REPORTED THAT UPON FURTHER INSPECTION, CRACKS WERE IDENTIFIED IN THE TUBING. THE HEALTHCARE FACILITY REPORTED THAT THE CANNULA WAS REPLACED AND THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22147188 ↗MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN BRAZIL REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF FOUR OF THE OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULAS WAS DETACHED DURING USE. THERE WERE NO CONSEQUENCES TO THE PATIENT/S REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22075113 ↗MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF A OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND BROKEN BETWEEN THE TUBING AND THE INTERFACE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597383 ↗MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND DETACHED BETWEEN THE TUBING AND THE INTERFACE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569256 ↗MalfunctionDec 30, 2024Break; Break
A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NMPA REPORTING SYSTEM THAT THE OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULA WAS BROKEN DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21035080 ↗MalfunctionAug 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN BRAZIL REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT 3 OF THEIR OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULAS WERE BROKEN. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULA'S TUBING WAS DETACHED FROM THE CANNULA TUBE JOINT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19966851 ↗MalfunctionAug 8, 2024Break; Break
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OPT316 OPTIFLOW JUNIOR INFANT NASAL CANNULA'S INTERFACE WAS BROKEN DURING USE ON A PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945662 ↗MalfunctionApr 23, 2024Break; Break
A HEALTHCARE FACILITY IN UNITED KINGDOM REPORTED VIA THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA ) THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR CANNULA WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169764 ↗MalfunctionMar 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891666 ↗MalfunctionNov 14, 2023Break; Break
A REGULATORY BODY REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN THE UNITED KINGDOM THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS SNAPPED ON ONE SIDE DURING USE. THERE WAS NO OBSERVED FORCE OR TRAUMA. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: Insufficient Information
MAUDE report 18136206 ↗MalfunctionNov 1, 2023Detachment 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 WHEN BEING USED ON THE SAME PATIENT, THREE OPT316 OPTIFLOW JUNIOR NASAL CANNULAS TUBING WERE FOUND TO HAVE DETACHED FROM THE SWIVEL GRIP TUBE JOINT. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18051662 ↗MalfunctionSep 14, 2023Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17752610 ↗MalfunctionSep 8, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED THAT THE TUBING OF A OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE WAS FOUND WHILST THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17711885 ↗MalfunctionAug 21, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
A DISTRIBUTOR, ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, REPORTED AN ISSUE WITH AN OPT316. OPTIFLOW JUNIOR NASAL CANNULA. UPON DEVICE EVALUATION AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND, IT WAS FOUND THAT THE NASAL PRONGS WERE OCCLUDED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17590030 ↗MalfunctionMay 24, 2023Break; Break
A REGULATORY BODY REPORTED, ON BEHALF OF A HEALTHCARE FACILITY IN BRAZIL, THAT AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA HAD BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16996798 ↗MalfunctionMar 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN GERMANY REPORTED, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE SWIVEL GRIP TUBE JOINT DURING PATIENT USE. THERE WAS NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637918 ↗
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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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