CPAP & Ventilators recalls

551 medical device recalls in the cpap & ventilators category are on file with the FDA, from 2012 to 26 Aug 2026.

Total recalls551since 2012

Last 12 months25reported

Class I24645% of total

Ongoing198latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

16Oct '24 5 0 3Jan '25 1 1 6Apr 5 2 3Jul 6 0 0Oct 1 5 1Jan '26 1 0 10Apr 1 2 1Jul 3 0

Severity split

Class I 246 45%Class II 297 54%Class III 8 1%

Why cpap & ventilators is recalled

Companies

By year

2026193%
2025336%
2024448%
2023387%
2022387%
20219718%
2020448%
2019244%
2018285%
201792%

Ongoing cpap & ventilators recalls

198 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo-n recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS I	Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	WI
24 Jun 2026Device	CLASS II	Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems	Inspire Medical Systems	Lead & Heavy Metals	Nationwide

All cpap & ventilators recalls, newest first

551 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo-n recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS I	Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	WI
24 Jun 2026Device	CLASS II	Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems	Inspire Medical Systems	Lead & Heavy Metals	Nationwide
13 May 2026Device	CLASS II	Biofire Spotfire Respiratory/Sore Throat Panel recalled	BioFire Diagnostics	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	React Health Phoenix Oxygen Concentrator recalled by 3B Medical	3B Medical	Other	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy EV300 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.