FISHER & PAYKEL HEALTHCARE RT041LRecalls & reported problems

Fisher & Paykel Healthcare Limited · Non Vented Mask · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09420012429858), received between Feb 3, 2021 and Aug 30, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

Most reported problems

Device problems

Detachment of Device or Device Component3
Break1
Material Separation1
Material Split, Cut or Torn1

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 30, 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 SEAL OF TWO RT041L NON-VENTED HOSPITAL FULL FACE MASKS DISCONNECTED FROM THE MASK FRAME. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17657824 ↗
MalfunctionMay 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE FACILITY IN COLORADO REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE SEAL OF A RT041L NON-VENTED HOSPITAL FULL FACE MASK DISCONNECTED FROM THE MASK FRAME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989974 ↗
MalfunctionMar 17, 2022Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE SEAL OF TEN RT041 FULL FACE MASKS DISCONNECTED FROM THE MASK FRAME. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13794887 ↗
MalfunctionFeb 3, 2021Break; Break; Material Split, Cut or Torn
A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SOUTH AFRICA VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE VELCRO TORE FROM THE HEADGEAR STRAP OF A RT041 NON-VENTED HOSPITAL FULL FACE MASK DURING USE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11276768 ↗

Device details

UDI-DI	`09420012429858`
Brand	FISHER & PAYKEL HEALTHCARE
Model	RT041L
Company	Fisher & Paykel Healthcare Limited
Product code	CBK · Ventilator, Continuous, Facility Use
Class	Class 2
FDA submission	K083122
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 1, 2026

Device type (GMDN): CPAP/BPAP face mask, single-use

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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All Ventilator, Continuous, Facility Use devices →

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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