FDA Device Intelligence
HomeDevice types › MNS

Ventilator, Continuous, Non-Life-Supporting

FDA product code MNS · Class 2 · Anesthesiology

789
Registered devices
11,195
Adverse events
21
Recalls
47
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-07-15BMC Medical Co., Ltd.Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
2025-05-09Philips Respironics, Inc.This device does not indicate for use in patients with respiratory failure.
2025-05-09Philips Respironics, Inc.This device does not indicate for use in patients with respiratory failure.
2024-04-01Philips Respironics, Inc.Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia,
2024-03-26Philips Respironics, Inc.Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxem
2024-03-26Philips Respironics, Inc.Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxem
2022-08-26Philips Respironics, Inc.Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
2022-08-26Philips Respironics, Inc.Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
2022-08-26Philips Respironics, Inc.Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
2022-08-26Philips Respironics, Inc.Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.