Vyaire Medical recalls
Every recall we track for Vyaire Medical — 23 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them. 11 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Vyaire Medical fell by more than half in 2025 (2, down from 9 in 2024). 48% rated “stop using now”.
All FDA recall records for Vyaire Medical since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 0 | 0 | 1 |
| 2018 | 0 | 3 | 0 | 0 | 3 |
| 2019 | 0 | 1 | 1 | 1 | 3 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 2 | 1 | 1 | 4 |
| 2024 | 9 | 0 | 0 | 0 | 9 |
| 2025 | 2 | 0 | 0 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Vyaire Medical product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Vyaire Medical recalls
10 shown- Stop using nowMedical device
Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A
Vyaire Medical recalls AirLife Infant Heated Wire Circuit model AH165 due to risk of disconnection during use, which can cause severe health issues in neonates.
AirLifeApr 10, 2025 - Stop using nowMedical device
Vyaire Medical recalls AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Vyaire Medical recalls AirLife Adult Manual Resuscitators with faulty oxygen tubing that may cause hypoventilation or hypoxia, potentially leading to death. Affected units have manufacturing dates of 2017 or earlier.
Vyaire MedicalJan 10, 2024 - Lower riskMedical device
Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory
Vyaire Medical recalls 3100A Flexible Patient Circuits with serial numbers 4022993-4253792 that were distributed in the U.S. despite being approved only for non-U.S. use. This poses a risk of improper use.
Vyaire MedicalOct 27, 2023 - Use cautionMedical device
Vyaire Medical recalls bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Vyaire Medical recalls Bellavista 1000e ventilators with software version 6.1.0.2 or 6.1.1 due to touchscreen unresponsiveness and potential use errors that could disrupt patient care.
Vyaire MedicalMay 5, 2023 - Use cautionMedical device
Vyaire Medical recalls bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista
Vyaire Medical recalls Bellavista 1000 and 1000e ventilators with specific serial numbers due to potential breathing support failure. Affected units may need repair or replacement.
Vyaire MedicalDec 20, 2021 - Use cautionMedical device
Vyaire Medical recalls bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic
Vyaire Medical recalls Bellavista 1000 ventilators with catalog number 301.100.030 due to intermittent failures including lack of high-priority alarms and non-responsive touch screens. Affected units have specific serial numbers listed in the recall.
Vyaire MedicalNov 25, 2019 - UnratedMedical device
Vyaire Medical recalls enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Vyaire Medical recalls enFlow Disposable Cartridges for intravenous warming therapy due to aluminum elution during fluid warming. Affected units distributed through March 7, 2019.
Vyaire MedicalMar 13, 2019 - Use cautionMedical device
Vyaire Medical recalls The Tri-Flo Subglottic Suction System
Vyaire Medical recalls Tri-Flo Subglottic Suction Systems with potential catheter break-off causing aspiration of foreign bodies. Affected units have specific part and serial numbers.
Vyaire MedicalJun 20, 2018 - Use cautionMedical device
Vyaire Medical recalls AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number
Vyaire Medical recalls AirLife Resuscitation Devices with potential airflow obstruction during oxygen delivery. Affected models include specific part numbers and lot numbers for adult use. Consumers should check their device details to determine if recalled.
Vyaire MedicalMay 8, 2018 - Use cautionMedical device
Vyaire Medical recalls AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2
Vyaire Medical recalls AirLife Reduced Heparin arterial blood samplers (lot #0001047501) due to incorrect needle and syringe size that could cause injury during blood draws.
Vyaire MedicalJul 18, 2017
Vyaire Medical recall questions
How many recalls has Vyaire Medical had?
23 recalls from Vyaire Medical are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Vyaire Medical recall?
Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A, dated Apr 10, 2025. Every Vyaire Medical recall is listed on this page, newest first.
What should I do if I have a recalled Vyaire Medical product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Vyaire Medical recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.