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 |
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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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