| Z-0481-2026 | Class II | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold a | October 7, 2025 |
| Z-2228-2025 | Class I | DreamStation Auto BiPAP. Non-Continuous Ventilator. | June 30, 2025 |
| Z-2227-2025 | Class I | DreamStation Auto CPAP. Non-Continuous Ventilator. | June 30, 2025 |
| Z-2229-2025 | Class I | DreamStation Auto. Non-Continuous Ventilator. | June 30, 2025 |
| Z-2035-2025 | Class I | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and ad | May 9, 2025 |
| Z-2037-2025 | Class I | BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating ad | May 9, 2025 |
| Z-2036-2025 | Class I | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric pa | May 9, 2025 |
| Z-0291-2025 | Class I | Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B | October 7, 2024 |
| Z-0293-2025 | Class I | Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B | October 7, 2024 |
| Z-0295-2025 | Class I | Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediat | October 7, 2024 |
| Z-0292-2025 | Class I | Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive v | October 7, 2024 |
| Z-0290-2025 | Class I | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B | October 7, 2024 |
| Z-0296-2025 | Class I | LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pedi | October 7, 2024 |
| Z-0294-2025 | Class I | Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatr | October 7, 2024 |
| Z-2943-2024 | Class I | Trilogy Evo Universal Ventilator, Model No. DS2000X11B | July 16, 2024 |
| Z-2942-2024 | Class I | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; | July 16, 2024 |
| Z-2944-2024 | Class I | Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilo | July 16, 2024 |
| Z-1817-2024 | Class I | OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1 | April 1, 2024 |
| Z-1812-2024 | Class I | BiPAP V30 Auto Ventilator, Part Number 1111178 | March 26, 2024 |
| Z-1813-2024 | Class I | BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 111 | March 26, 2024 |