Vyaire Medical recalls

Vyaire Medical has 63 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 21 May 2025. 12 are still ongoing.

Total recalls63since 2017

Last 12 months0reported

Class I5790% of total

Ongoing12latest 21 May 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 2May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 57 90%Class II 6 10%Class III 0 0%

Why vyaire medical is recalled

Product types

By year

202523%
20241016%
202346%
202212%
202012%
201923%
20184267%
201712%

Ongoing vyaire medical recalls

12 active

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide

All vyaire medical recalls, newest first

63 total

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
21 May 2025Device	CLASS I	AirLife Infant Heated Wire Circuit recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, Oxygen Reservoir, without Mask recalled	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, Oxygen Reservoir recalled	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, Oxygen Reservoir recalled	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
6 Mar 2024Device	CLASS I	AirLife Adult Manual Resuscitator, 40" recalled by Vyaire Medical	Vyaire Medical	Mold	Nationwide
13 Dec 2023Device	CLASS II	vyaire Flexible Patient Circuit, 3100A recalled by Vyaire Medical	Vyaire Medical	Other	FL
13 Dec 2023Device	CLASS II	vyaire Flexible Patient Circuit, 3100A recalled by Vyaire Medical	Vyaire Medical	Other	FL
21 Jun 2023Device	CLASS II	bellavista 1000 Ventilator recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
21 Jun 2023Device	CLASS II	bellavista 1000e Ventilator recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
23 Feb 2022Device	CLASS I	bellavista 1000 ventilator recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
11 Mar 2020Device	CLASS II	bellavista 1000 ventilator recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	Nationwide
3 Jul 2019Device	CLASS I	enFlow Disposable Cartridge with IV Extension Set, used recalled	Vyaire Medical	Other	Nationwide
3 Jul 2019Device	CLASS I	enFlow Disposable Cartridge, used recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
29 Aug 2018Device	CLASS I	The Tri-Flo Subglottic Suction System recalled by Vyaire Medical	Vyaire Medical	Device Malfunction	18 states
15 Aug 2018Device	CLASS I	AirLife Resuscitation Device, Pediatric labeled as the following recalled	Vyaire Medical	Other	28 states
15 Aug 2018Device	CLASS I	AirLife Resuscitation Device, Adult labeled as the following recalled	Vyaire Medical	Other	28 states
16 May 2018Device	CLASS I	AirLife Resuscitation, Infant recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
16 May 2018Device	CLASS I	AirLife Resuscitation, Adult, with mask, oxygen reservoir recalled	Vyaire Medical	Other	Nationwide
16 May 2018Device	CLASS I	AirLife Resuscitation, Adult, with mask recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
16 May 2018Device	CLASS I	AirLife Resuscitation, Adult, with mask, oxygen reservoir, filter recalled	Vyaire Medical	Other	Nationwide
16 May 2018Device	CLASS I	AirLife Resuscitation, Adult recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
16 May 2018Device	CLASS I	AirLife Resuscitation, Infant recalled by Vyaire Medical	Vyaire Medical	Other	Nationwide
16 May 2018Device	CLASS I	AirLife Resuscitation, Adult, with mask, oxygen reservoir recalled	Vyaire Medical	Other	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.