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Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Medium Adult

SLEEPNET, CORP. · Model 22640 · UDI-DI 00814747020432

CBK Prescription

510(k) clearances

213,383

Adverse events (2,259 deaths)

323

Recalls

129

Facilities

Description

Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.

Recalls

Date	Firm	Reason
2026-06-30	Maquet Critical Care AB	Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical te
2026-06-25	ResMed Ltd.	Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
2026-05-08	Ventec Life Systems, Inc.	Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the back
2026-03-02	Philips Respironics, Inc.	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
2026-03-02	Philips Respironics, Inc.	In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
2026-03-02	Philips Respironics, Inc.	In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
2026-03-02	Philips Respironics, Inc.	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
2026-03-02	Philips Respironics, Inc.	Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
2026-03-02	Philips Respironics, Inc.	In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
2026-03-02	Philips Respironics, Inc.	In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.