Category

Respiratory Devices Recalls

629 respiratory devices recalls on record from CPSC, FDA, and USDA.

629 recalls
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are...
Respiratory Devices·20 affected·Apr 27, 2017
CriticalFDA
Respironics California Inc
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617...
Respiratory Devices·30,516 affected·Apr 24, 2017
High RiskFDA
Vortran Medical Technology 1, Inc
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used b...
Respiratory Devices·14 affected·Apr 20, 2017
High RiskFDA
Valeant Pharmacueticals International
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for th...
Respiratory Devices·418 affected·Mar 13, 2017
High RiskFDA
Del Mar Reynolds Medical, Ltd.
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed...
Respiratory Devices·325 affected·Feb 8, 2017
High RiskFDA
Covidien Llc
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use wh...
Respiratory Devices·7,453 affected·Dec 16, 2016
High RiskFDA
Parker Medical
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL...
Respiratory Devices·1,060 affected·Dec 16, 2016
CriticalFDA
Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neo...
Respiratory Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled...
Respiratory Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to pr...
Respiratory Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant ...
Respiratory Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlle...
Respiratory Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can...
Respiratory Devices·5,993 affected·Nov 18, 2016
CriticalFDA
Ohmeda Medical
IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregul...
Respiratory Devices·5,993 affected·Nov 18, 2016
High RiskFDA
Medtronic Inc
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The...
Respiratory Devices·5,609 affected·Nov 16, 2016
High RiskFDA
Thayer Medical Corporation
Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm D...
Respiratory Devices·2,550 affected·Sep 29, 2016
High RiskFDA
Hamilton Medical, Inc.
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and p...
Respiratory Devices·44 affected·Sep 26, 2016
High RiskFDA
Inovo, Inc
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill port...
Respiratory Devices·117 affected·Jul 21, 2016
High RiskFDA
Resmed Corporation
Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Respiratory Devices·42 affected·Jul 12, 2016
High RiskFDA
Carefusion 2200 Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Respiratory Devices·544 affected·Jun 29, 2016
High RiskFDA
Invacare Corporation
Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter ad...
Respiratory Devices·395 affected·Jun 21, 2016
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic ...
Respiratory Devices·167 affected·Jun 15, 2016
CriticalFDA
Draeger Medical, Inc.
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient brea...
Respiratory Devices·42,922 affected·May 31, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation a...
Respiratory Devices·875 affected·May 24, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a pr...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or ...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum pati...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing ...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Carefusion 211 Inc Dba Carefusion
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum...
Respiratory Devices·922 affected·May 17, 2016
CriticalFDA
Medtronic
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack...
Respiratory Devices·9,817 affected·Apr 13, 2016
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patien...
Respiratory Devices·952 affected·Mar 15, 2016
High RiskFDA
Ventlab Llc
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical s...
Respiratory Devices·2,430 affected·Mar 15, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provid...
Respiratory Devices·222 affected·Mar 14, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Respiratory Devices·72,000 affected·Feb 23, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Respiratory Devices·72,000 affected·Feb 23, 2016
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Respiratory Devices·72,000 affected·Feb 23, 2016
CriticalFDA
Draeger Medical, Inc.
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Respiratory Devices·2,553 affected·Feb 4, 2016
High RiskFDA
Philips Respironics
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus prov...
Respiratory Devices·104,508 affected·Jan 18, 2016
High RiskFDA
Resmed Corporation
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the lar...
Respiratory Devices·14,736 affected·Jan 13, 2016
CriticalFDA
Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventil...
Respiratory Devices·0 affected·Dec 22, 2015
CriticalFDA
Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704...
Respiratory Devices·402 affected·Dec 22, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia...
Respiratory Devices·84 affected·Dec 15, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesi...
Respiratory Devices·2 affected·Dec 15, 2015
CriticalFDA
Draeger Medical, Inc.
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit inten...
Respiratory Devices·2,422 affected·Dec 1, 2015
CriticalFDA
Thornhill Research Inc
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES...
Respiratory Devices·83 affected·Nov 19, 2015
CriticalFDA
Thornhill Research Inc
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ven...
Respiratory Devices·178 affected·Nov 19, 2015