Fisher and Paykel Healthcare OPT312Recalls & reported problems
Fisher & Paykel Healthcare Limited · Optiflow Junior Premature Nasal Cannula · Class 1
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 09420012432278), received between Sep 28, 2018 and Sep 16, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component11
- Break10
- Material Split, Cut or Torn5
- Disconnection2
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 22 most recent of 22 reports, 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 ↗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 ↗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 ↗MalfunctionNov 16, 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 OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS DETACHED FROM THE CONNECTOR END (SWIVEL GRIP). THERE WERE NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23565705 ↗MalfunctionDec 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE OPT312 OPTIFLOW JUNIOR INFANT NASAL CANNULA BECAME LOOSE DURING PATIENT USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20948150 ↗MalfunctionApr 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR CANNULA WAS BROKEN DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19199232 ↗MalfunctionMar 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA HAD DETACHED FROM THE CANNULA TUBE JOINT DURING PATIENT USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966572 ↗MalfunctionFeb 1, 2024Break; Break
A DISTRIBUTOR REPORTED, ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, THAT AN OPT312 OPTIFLOW JUNIOR CANNULA WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18628536 ↗MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN OPT312 OPTIFLOW JUNIOR CANNULA WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619912 ↗MalfunctionDec 21, 2023Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN OPT312 OPTIFLOW JUNIOR CANNULA WAS DAMAGED DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18380167 ↗MalfunctionDec 21, 2023Break; Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND TO BE BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18378977 ↗MalfunctionDec 19, 2023Break; Break
A HEALTHCARE FACILITY IN CHINA REPORTED THAT AN OPT312 OPTIFLOW JUNIOR CANNULA WAS 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 18361309 ↗MalfunctionDec 13, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND TO BE BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317224 ↗MalfunctionMar 2, 2022Disconnection; Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN THE (B)(6) REPORTED THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR NASAL CANNULA WAS FOUND DISCONNECTED FROM THE NASAL CANNULA BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13654833 ↗MalfunctionSep 30, 2021Break
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA THAT THE INTERFACE OF AN OPT312 OPTIFLOW JUNIOR CANNULA WAS FOUND BROKEN AFTER TWO DAYS OF USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557990 ↗MalfunctionJun 3, 2021Break; Break
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE INTERFACE OF AN OPT312 OPTIFLOW JUNIOR CANNULA WAS FOUND TO BE DAMAGED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11936647 ↗MalfunctionJun 3, 2021Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A DISTRIBUTOR IN CHINA REPORTED ON BEHALF OF A HEALTHCARE FACILITY THAT THE INTERFACE OF AN OPT312 OPTIFLOW JUNIOR CANNULA WAS FOUND TO BE DAMAGED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11936626 ↗MalfunctionMay 20, 2021Break
A DISTRIBUTOR IN CHINA REPORTED THAT THE TUBING OF AN OPT312 OPTIFLOW JUNIOR CANNULA WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860967 ↗MalfunctionMar 31, 2021Disconnection; Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
A HEALTHCARE FACILITY IN CHINA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT AN OPT312 OPTIFLOW JUNIOR CANNULA WAS FOUND DISCONNECTED FROM THE NASAL CANNULA AFTER SIX DAYS OF USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600228 ↗MalfunctionSep 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HOSPITAL THAT THE LOOP PAD ON AN OPT312 JUNIOR INTERFACE WIGGLEPAD HAD COME LOOSE FROM THE PLASTIC. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7917300 ↗MalfunctionSep 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR IN (B)(4) REPORTED ON BEHALF OF A HOSPITAL THAT THE PAD ON THREE OPT312 JUNIOR INTERFACE WIGGLE PADS HAD COME LOOSE FROM THE PLASTIC. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7917294 ↗
Other Cannula, Nasal, Oxygen devices
- Fisher & Paykel Healthcare OPT844Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen39 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 reports
- Adult Soft Tip Cannula with 7' 85 Shore Green Tubing 0556Westmed, Inc. · Cannula, Nasal, Oxygen5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.