Philips Respironics, Inc.
Philips Respironics, Inc. holds FDA 510(k) medical device clearance, cleared in 2011, with 93 FDA device recalls on record.
Top product codes for Philips Respironics, Inc.
FDA recalls by Philips Respironics, Inc.
10 most recent of 93- Z-1617-2026 — Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1616-2026 — Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1615-2026 — Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1647-2026 — Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1649-2026 — Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1648-2026 — Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1646-2026 — Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-1614-2026 — Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Z-0481-2026 — SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
- Z-2227-2025 — DreamStation Auto CPAP. Non-Continuous Ventilator.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Respironics, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.