CPAP & Ventilators recalls

556 medical device recalls in the cpap & ventilators category are on file with the FDA, from 2012 to 21 Oct 2026. The leading reason is device malfunction.

Total recalls556since 2012

Last 12 months30reported

Class I24845% of total

Ongoing203latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

5Nov '24 0 3 1Feb 1 6 5May 2 3 6Aug 0 0 1Nov 5 1 1Feb 0 10 1May 2 1 3Aug 3 2

Severity split

Class I 248 45%Class II 300 54%Class III 8 1%

Why cpap & ventilators is recalled

Companies

By year

2026244%
2025336%
2024448%
2023387%
2022387%
20219717%
2020448%
2019244%
2018285%
201792%

Ongoing cpap & ventilators recalls

203 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide

All cpap & ventilators recalls, newest first

556 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	Multiple-type respiratory pathogen nucleic acid IVD, kit recalled	BioFire Diagnostics	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (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	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	Potency & Assay	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
8 Apr 2026Device	CLASS I	Blue Ventilator Adapter Module, single-patient use circuit recalled	Baxter Healthcare	Other	FL
8 Apr 2026Device	CLASS I	Trilogy Evo Universal recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo O2 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy Evo O2 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy EV300 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy Evo Universal recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
18 Feb 2026Device	CLASS II	Medline Suction Catheter Kits recalled by Medline Industries	Medline Industries	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	EDAN Patient Monitor recalled by Edan Diagnostics	Edan Diagnostics	Device Malfunction	Nationwide
17 Dec 2025Device	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states
17 Dec 2025Device	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states
17 Dec 2025Device	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states
17 Dec 2025Device	CLASS I	ErgoStar CM recalled by Draeger	Draeger	Device Malfunction	10 states
3 Dec 2025Device	CLASS II	BioFire Respiratory Panel 2.1, IVD recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	10 states
19 Nov 2025Device	CLASS II	SimplyGo Mini, Standard Battery Kit recalled by Philips Respironics	Philips Respironics	Temperature Abuse	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.