Fisher & Paykel Healthcare RT042LRecalls & reported problems
Fisher & Paykel Healthcare Limited · Bi-Level CPAP System Hospital Mask- Large Vented Nasal Mask · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09420012430243), received between Feb 1, 2024 and Feb 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN ILLINOIS REPORTED VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE SEAL OF A RT042L VENTED HOSPITAL NASAL MASKS WERE DETACHING FROM THE MASK FRAME. THE HEALTHCARE FACILITY HAS ALSO INDICATED THERE WERE OTHER RT042L VENTED HOSPITAL NASAL MASKS FROM THE SAME BATCH NUMBERS WITH THE SAME ISSUE HOWEVER THIS IS STILL TO BE CONFIRMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18628619 ↗
Other Mask, Oxygen devices
- HUDSON RCI HUDRHO41UMedline Industries, Inc. · MASK, OXYGEN1 recall27 reports
- HUDSON RCI HUD1930Medline Industries, Inc. · MASK, OXYGEN1 recall12 reports
- Mask, Adult Aerosol, Vented 0250Westmed, Inc. · Mask, Oxygen8 reports
- AcuCare 60788Resmed Pty Ltd · Mask, Oxygen4 reports
- F&P FlexiTrunk BC801-10Fisher & Paykel Healthcare Limited · Mask, Oxygen4 reports
- Disposable Face Mask 000252956Ambu A/S · MASK, OXYGEN4 reports
- HUDSON RCI HUD1007Medline Industries, Inc. · MASK, OXYGEN4 reports
- F&P FlexiTrunk BC802-10Fisher & Paykel Healthcare Limited · Mask, Oxygen2 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page