Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Nephron Pharmaceuticals Corp.
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains s...
Respiratory Devices·11,208 affected·Nov 16, 2015
CriticalFDA
Event Medical Ltd
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare profess...
Respiratory Devices·6,441 affected·Oct 13, 2015
High RiskFDA
Precision Medical, Inc.
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen p...
Respiratory Devices·315 affected·Oct 8, 2015
High RiskFDA
Instrumentation Industries Inc
Ventilator Tubing
Respiratory Devices·567 affected·Sep 23, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gase...
Respiratory Devices·30 affected·Sep 3, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and ...
Respiratory Devices·4,638 affected·Aug 7, 2015
High RiskFDA
Radiometer America Inc
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and...
Respiratory Devices·4,244 affected·Jul 16, 2015
CriticalFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonat...
Respiratory Devices·657 affected·Jul 16, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole b...
Respiratory Devices·82 affected·Jul 14, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole b...
Respiratory Devices·82 affected·Jul 14, 2015
High RiskFDA
Nordicneurolab As
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to ...
Respiratory Devices·121 affected·Jul 3, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Respiratory Devices·105,831 affected·Jun 29, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial ox...
Respiratory Devices·211,426 affected·Jun 29, 2015
High RiskFDA
Alere Scarborough, Inc. Dba Binax, Inc.
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Inst...
Respiratory Devices·257 affected·Jun 26, 2015
High RiskFDA
O-two Medical Technologies, Inc.
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: T...
Respiratory Devices·4,382 affected·Jun 23, 2015
High RiskFDA
Oxysure Systems, Inc.
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
Respiratory Devices·1,005 affected·Jun 12, 2015
High RiskFDA
Hamilton Medical, Inc.
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Med...
Respiratory Devices·154 affected·Jun 1, 2015
High RiskFDA
Hamilton Medical, Inc.
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Me...
Respiratory Devices·154 affected·Jun 1, 2015
CriticalFDA
Teleflex Medical
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with...
Respiratory Devices·9,333 affected·May 14, 2015
High RiskFDA
Ge Healthcare
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 mon...
Respiratory Devices·5,018 affected·Apr 24, 2015
CriticalFDA
Carefusion 211 Inc Dba Carefusion
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assi...
Respiratory Devices·15,905 affected·Apr 3, 2015
High RiskFDA
Sentec Ag
Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital...
Respiratory Devices·129 affected·Mar 25, 2015
High RiskFDA
Hamilton Medical, Inc.
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ...
Respiratory Devices·248 affected·Mar 24, 2015
High RiskFDA
Del Mar Reynolds Medical, Ltd.
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designe...
Respiratory Devices·1,040 affected·Mar 5, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ve...
Respiratory Devices·3,213 affected·Jan 27, 2015
High RiskFDA
Ino Therapeutics (dba Ikaria)
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Respiratory Devices·45 affected·Jan 14, 2015
High RiskFDA
Teleflex Medical
LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway du...
Respiratory Devices·2,640 affected·Jan 13, 2015
High RiskFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is desi...
Respiratory Devices·418 affected·Jan 12, 2015
CriticalFDA
Vyaire Medical
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidifica...
Respiratory Devices·16,670 affected·Nov 29, 2014
CriticalFDA
Vyaire Medical
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The A...
Respiratory Devices·16,670 affected·Nov 29, 2014
High RiskFDA
Aptalis Pharmatech Inc.
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, in...
Respiratory Devices·49,000 affected·Nov 13, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (compris...
Respiratory Devices·2,506 affected·Nov 7, 2014
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorpor...
Respiratory Devices·331 affected·Oct 17, 2014
CriticalFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Respiratory Devices·324 affected·Oct 1, 2014
CriticalFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to pr...
Respiratory Devices·324 affected·Oct 1, 2014
High RiskFDA
Masimo Corporation
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of ...
Respiratory Devices·21,754 affected·Sep 30, 2014
High RiskFDA
Philips Medical Systems, Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva i...
Respiratory Devices·168 affected·Sep 24, 2014
CriticalFDA
Respironics California Inc
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-c...
Respiratory Devices·2,206 affected·Sep 17, 2014
High RiskFDA
Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-...
Respiratory Devices·2,421 affected·Sep 2, 2014
High RiskFDA
Aerogen Ltd.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-...
Respiratory Devices·36 affected·Sep 2, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ Syst...
Respiratory Devices·387 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended...
Respiratory Devices·1,005 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended ...
Respiratory Devices·22,828 affected·Aug 13, 2014
High RiskFDA
Vapotherm, Inc.
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is int...
Respiratory Devices·865 affected·Aug 13, 2014
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service ...
Respiratory Devices·748 affected·Aug 8, 2014
CriticalFDA
Carefusion 203, Inc.
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or m...
Respiratory Devices·1,729 affected·Aug 8, 2014
High RiskFDA
Teleflex Medical
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson He...
Respiratory Devices·11,679 affected·Jul 9, 2014
High RiskFDA
Teleflex Medical
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ven...
Respiratory Devices·11,679 affected·Jul 9, 2014