Vyaire Medical

Complete recall history across all FDA and CPSC categories — 62 total recalls

Vyaire Medical appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (62)

FDA medical device enforcement actions by Vyaire Medical. Showing most recent 50.

Date Product Reason Class
Apr 10, 2025 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... Adapters may disconnect during setup or while in use, potentially interruptin... Class I
Apr 10, 2025 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... Adapters may disconnect during setup or while in use, potentially interruptin... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Jan 10, 2024 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... Risk of hypoventilation caused by duckbill and ring broken/disassembled, due ... Class I
Oct 27, 2023 vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used wi... Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Os... Class II
Oct 27, 2023 vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used wi... Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Os... Class II
May 5, 2023 bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent... Vyaire Medical identified two patient safety risks during the use of the bell... Class II
May 5, 2023 bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven... Vyaire Medical identified two patient safety risks during the use of the bell... Class II
Dec 20, 2021 bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... Potential cessation in ventilation can occur under specific conditions. Class I
Nov 25, 2019 bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an ele... The G6 bellavista 1000 US ventilators may experience intermittent failures: ... Class II
Mar 13, 2019 enFlow Disposable Cartridge with IV Extension Set, used for intravenous warmi... Testing has demonstrated aluminum elution from the enFlow Disposable Cartrid... Class I
Mar 13, 2019 enFlow Disposable Cartridge, used for intravenous warming therapy with fluid ... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridg... Class I
Jun 20, 2018 The Tri-Flo Subglottic Suction System Vyaire Medical has discovered potential patient safety risk with associated w... Class I
May 8, 2018 AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... An error in manufacturing of the AirLife Resuscitation Devices that has the p... Class I
May 8, 2018 AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... An error in manufacturing of the AirLife Resuscitation Devices that has the p... Class I
Jul 18, 2017 AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE ... Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured cont... Class II
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usag... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Prod... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filt... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressu... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pr... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer,... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEE... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Replacement kit for outer shell, Broselow Product U... The mask component on various lots of the resuscitation devices have been ide... Class I
Apr 27, 2017 AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... The mask component on various lots of the resuscitation devices have been ide... Class I

View all 62 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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