F&P NeopuffRecalls & reported problems across all models
Fisher & Paykel Healthcare Limited · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 451
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of F&P Neopuff by Fisher & Paykel Healthcare Limited in the FDA's device registry (GUDID). Together they are named in 451 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2016 and Sep 30, 2026 — classified as 451 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (294 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 F&P Neopuff problems
Device problems
- Pressure Problem294
- Break150
- Output Problem11
- Physical Resistance/Sticking10
- Mechanical Problem9
- Loss of or Failure to Bond8
- Defective Component7
- Defective Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions401
- No Patient Involvement27
- No Known Impact Or Consequence To Patient23
- No Consequences Or Impact To Patient3
- Pneumothorax1
F&P Neopuff models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- F&P Neopuff RD900AEUWarmer, Infant Radiant433 reports
- F&P Neopuff RD900AFUWarmer, Infant Radiant18 reports
Recent F&P Neopuff adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Pressure Problem
A distributor in India reported reported via a Fisher & Paykel Healthcare (F&P) field representative that the gas inlet port of an RD900AEU Neopuff Infant Resuscitator was cracked.There was no reported patient consequence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941986 ↗MalfunctionSep 30, 2026Pressure Problem
A healthcare facility in Seattle reported that the RD900AEU Neopuff Infant Resuscitator failed the valve system test during device inspection, the pressure was observed to reach 83 cmH2O, exceeding the maximum pressure range indicated on the manometer.There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941876 ↗MalfunctionSep 21, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847241 ↗MalfunctionSep 15, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782307 ↗MalfunctionSep 10, 2026Break; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724453 ↗MalfunctionSep 10, 2026Physical Resistance/Sticking
A distributor in South Africa reported that the Peak Inspiratory Pressure knob and or the Max Pressure Relief knob of four RD900AEU Neopuff Infant Resuscitator was not rotating smoothly during acceptance checks. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704330 ↗MalfunctionSep 10, 2026Break
A healthcare facility in Texas reported that the gas outlet port of a RD900AEU Neopuff Infant Resuscitator was broken. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50704329 ↗MalfunctionSep 4, 2026Physical Resistance/Sticking
A distributor in South Africa reported that the Peak Inspiratory Pressure knob and or Max Pressure Relief knob of twenty-five RD900AEU Neopuff Infant Resuscitator was not rotating smoothly during acceptance checks. There was no reported patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50601047 ↗MalfunctionSep 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596115 ↗MalfunctionSep 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596112 ↗MalfunctionSep 3, 2026Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596108 ↗MalfunctionSep 1, 2026Break; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554043 ↗MalfunctionAug 12, 2026Break; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217736 ↗MalfunctionJul 27, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003824 ↗MalfunctionJul 21, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25899729 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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