Fisher and Paykel HealthcareRecalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of Fisher and Paykel Healthcare by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2018 and Sep 16, 2026 — classified as 103 malfunctions.
The most frequently reported specific device problem is “Break” (50 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 Fisher and Paykel Healthcare problems
Device problems
- Break50
- Detachment of Device or Device Component45
- Material Split, Cut or Torn26
- Disconnection2
- Gas/Air Leak2
- Contamination /Decontamination Problem1
- Fracture1
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- Low Oxygen Saturation5
- Insufficient Information4
- No Consequences Or Impact To Patient2
- Hypoxia1
Fisher and Paykel Healthcare models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fisher and Paykel Healthcare OPT316Humidifier, Respiratory Gas, (Direct Patient Interface)32 reports
- Fisher and Paykel Healthcare OPT318Humidifier, Respiratory Gas, (Direct Patient Interface)31 reports
- Fisher and Paykel Healthcare OPT312Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Cannula, Nasal, Oxygen17 reports
- Fisher and Paykel Healthcare MYOPT9MEDIUMHumidifier, Respiratory Gas, (Direct Patient Interface)1 report
Recent Fisher and Paykel Healthcare adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796924 ↗MalfunctionAug 13, 2026Material Split, Cut or Torn
A healthcare facility in China reported via the National Medical Products Administration (NMPA) reporting system that the tubing of an OPT312 Optiflow Junior Infant Nasal Cannula was found to be broken at the connector end (Swivel grip).There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230743 ↗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 ↗MalfunctionMay 15, 2026Break; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED FROM THE CANNULA END DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO CONTINUE THERAPY AND THAT THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179887 ↗MalfunctionApr 24, 2026Break
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE OPT318 OPTIFLOW JUNIOR NASAL CANNULA WAS BROKEN DURING USE. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24977723 ↗MalfunctionApr 23, 2026Unraveled Material; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA ON BEHALF OF A HEALTHCARE FACILITY REPORTED THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS TORN DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972396 ↗MalfunctionMar 31, 2026Break; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN IRELAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL 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 24750337 ↗MalfunctionMar 13, 2026Break
A HEALTHCARE FACILITY IN CHINA HAS REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT314 OPTIFLOW JUNIOR NEONATAL NASAL CANNULA WAS DETACHED DURING USE ON A PATIENT. IT WAS FURTHER REPORTED THAT THE CANNULA WAS REPLACED TO CONTINUE THERAPY AND THAT THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587752 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. THE HEALTHCARE FACILITY REPORTED A TEMPORARY DROP IN THE PATIENT'S OXYGEN SATURATION. IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED TO CONTINUE THE THERAPY, WITH NO FURTHER REPORTED PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation
MAUDE report 24450986 ↗MalfunctionFeb 25, 2026Detachment of Device or Device Component
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE TUBING OF THE OPT314 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM CANNULA END DURING USE. IT WAS ALSO REPORTED THAT THE SUBJECT DEVICE WAS IMMEDIATELY REPLACED TO CONTINUE THE THERAPY, WITH NO FURTHER REPORTED PATIENT CONSEQUENCES.
Patient problems: Low Oxygen Saturation
MAUDE report 24450934 ↗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 21, 2026Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CHINA REPORTED VIA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) REPORTING SYSTEM THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED DURING USE. IT WAS ALSO REPORTED THAT THE CANNULA WAS REPLACED. FISHER & PAYKEL HEALTHCARE (F&P) HAS REQUESTED FURTHER INFORMATION RELATED TO THE REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24141714 ↗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 ↗MalfunctionDec 18, 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 OPT318 OPTIFLOW JUNIOR PEDIATRIC NASAL CANNULA DETACHED FROM THE CANNULA END. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846921 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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