Recall archive
13 recalls · page 1 of 1
Reported May 21, 2025
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical, Inc.
Matched: Brand · Product · Product details — Potential of the nozzle separating during patient use.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
Matched: Brand · Product · Product details — Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
Matched: Brand · Reason for recall — Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 23, 2022
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — Potential cessation in ventilation can occur under specific conditions.
FDA (openFDA device enforcement)
Reported Mar 11, 2020
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
Matched: Brand — The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition,…
FDA (openFDA device enforcement)
Reported Jul 3, 2019
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 29, 2018
The Tri-Flo Subglottic Suction System
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand · Reason for recall — Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the…
FDA (openFDA device enforcement)
Reported Aug 15, 2018
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 16, 2018
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which…
34 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2018
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical
Matched: Brand — Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2017
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
Matched: Brand — Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23…
FDA (openFDA device enforcement)
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