Category

Respiratory Devices Recalls

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

629 recalls
CriticalFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i ...
Respiratory Devices·90,000 affected·Mar 7, 2013
High RiskFDA
Maquet Cardiovascular, Llc
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxyg...
Respiratory Devices·154 affected·Mar 7, 2013
High RiskFDA
Devilbiss Healthcare Llc
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6...
Respiratory Devices·112,849 affected·Mar 7, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedu...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use dur...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedure...
Respiratory Devices·3,972 affected·Feb 27, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended f...
Respiratory Devices·3,972 affected·Feb 27, 2013
CriticalFDA
Smiths Medical Asd, Inc.
Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiratio...
Respiratory Devices·39 affected·Feb 6, 2013
High RiskFDA
Oxus America, Inc.
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable ...
Respiratory Devices·1,724 affected·Jan 14, 2013
RecallFDA
Diagnostic Hybrids Inc
Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplificat...
Respiratory Devices·13,005 affected·Dec 31, 2012
CriticalFDA
Praxair Inc.
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxyg...
Respiratory Devices·320,451 affected·Nov 16, 2012
High RiskFDA
Sentec Ag
SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign...
Respiratory Devices·265 affected·Nov 5, 2012
High RiskFDA
Del Mar Reynolds Medical, Ltd.
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both...
Respiratory Devices·3 affected·Nov 2, 2012
CriticalFDA
Ge Healthcare, Llc
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Pand...
Respiratory Devices·276 affected·Oct 15, 2012
CriticalFDA
Newport Medical Instruments Inc
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to p...
Respiratory Devices·72 affected·Aug 3, 2012
CriticalFDA
Respironics California Inc
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intend...
Respiratory Devices·197 affected·Jul 31, 2012
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for u...
Respiratory Devices·12,779 affected·Jul 20, 2012
CriticalFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC...
Respiratory Devices·337,227 affected·Jul 18, 2012
CriticalFDA
Ventlab Corporation
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure mon...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is int...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Res...
Respiratory Devices·14,602 affected·Jul 11, 2012
CriticalFDA
Ventlab Corporation
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 Th...
Respiratory Devices·14,602 affected·Jul 11, 2012
High RiskFDA
Sentec Ag
SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of v...
Respiratory Devices·8 affected·Jul 9, 2012
High RiskFDA
Opti Medical Systems, Inc
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in v...
Respiratory Devices·895 affected·Jul 3, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the ...
Respiratory Devices·1,095 affected·Jun 22, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6...
Respiratory Devices·648 affected·Jun 22, 2012
CriticalFDA
Carefusion 203, Inc.
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum ...
Respiratory Devices·266 affected·Jun 19, 2012
High RiskFDA
Salter Labs
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient U...
Respiratory Devices·242 affected·May 30, 2012
CriticalFDA
Carefusion 2200 Inc
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; ...
Respiratory Devices·0 affected·May 29, 2012
CriticalFDA
Carefusion 2200 Inc
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi...
Respiratory Devices·0 affected·May 29, 2012
CriticalFDA
Carefusion 2200 Inc
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ran...
Respiratory Devices·0 affected·May 29, 2012
High RiskFDA
Philips Healthcare Inc.
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cab...
Respiratory Devices·433 affected·May 21, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Respiratory Devices·7,889 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Respiratory Devices·335 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
Respiratory Devices·82 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.
Respiratory Devices·1,599 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Respiratory Devices·0 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Respiratory Devices·730 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Respiratory Devices·18,114 affected·May 1, 2012
CriticalFDA
Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Respiratory Devices·14,585 affected·May 1, 2012
CriticalFDA
Respironics, Inc.
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory supp...
Respiratory Devices·173 affected·Apr 27, 2012
RecallFDA
Impact Instrumentation, Inc.
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of ...
Respiratory Devices·0 affected·Mar 19, 2012
High RiskFDA
Princeton Biomeditech Corp
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-7...
Respiratory Devices·103 affected·Mar 9, 2012
High RiskFDA
Princeton Biomeditech Corp
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B te...
Respiratory Devices·90 affected·Mar 9, 2012
CriticalFDA
Maquet Cardiovascular Us Sales, Llc
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for pati...
Respiratory Devices·284 affected·Feb 20, 2012