Home › SLEEPNET, CORP. › Veraseal 2 Full Face Non Vented Mask, Small

Veraseal 2 Full Face Non Vented Mask, Small

SLEEPNET, CORP. · Model 50933 · UDI-DI 00814747020005

CBK Prescription

510(k) clearances

213,383

Adverse events (2,259 deaths)

323

Recalls

128

Facilities

Description

Disposable full face non vented mask 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.	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.	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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.