Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Pro...
Respiratory Devices·1,239 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monito...
Respiratory Devices·3,425 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG ...
Respiratory Devices·0 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG...
Respiratory Devices·0 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Pro...
Respiratory Devices·1,089 affected·Jul 21, 2020
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and dif...
Respiratory Devices·1,474 affected·Jul 15, 2020
High RiskFDA
Precision Valve & Automation,inc
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motor...
Respiratory Devices·3 affected·Jun 26, 2020
High RiskFDA
Roi Cps Llc
Respirator Crash Cart Kit
Respiratory Devices·200 affected·May 19, 2020
High RiskFDA
Philips North America, Llc
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen satura...
Respiratory Devices·1 affected·May 19, 2020
High RiskFDA
Mediana Co., Ltd.
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (N...
Respiratory Devices·180 affected·May 15, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Respironics California, Llc
Philips V60 Ventilators with Power Management PCBA part number 1055906
Respiratory Devices·23,581 affected·Mar 5, 2020
High RiskFDA
Breas Medical, Inc.
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 6...
Respiratory Devices·629 affected·Jan 28, 2020
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC...
Respiratory Devices·27,165 affected·Dec 6, 2019
High RiskFDA
Vyaire Medical
bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an ...
Respiratory Devices·116 affected·Nov 25, 2019
CriticalFDA
Ge Healthcare, Llc
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory su...
Respiratory Devices·280 affected·Nov 25, 2019
High RiskFDA
Caire, Inc.
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the adminis...
Respiratory Devices·4 affected·Nov 21, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·16 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at lea...
Respiratory Devices·5 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2...
Respiratory Devices·48 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea...
Respiratory Devices·8 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least...
Respiratory Devices·105 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least ...
Respiratory Devices·29 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients wei...
Respiratory Devices·21 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·27 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at le...
Respiratory Devices·31 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing a...
Respiratory Devices·1 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing...
Respiratory Devices·15 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing a...
Respiratory Devices·21 affected·Nov 19, 2019
CriticalFDA
Philips Respironics, Inc.
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at...
Respiratory Devices·3 affected·Nov 19, 2019
High RiskFDA
Getinge Us Sales Llc
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Respiratory Devices·3,633 affected·Nov 13, 2019
High RiskFDA
Edwards Lifesciences, Llc
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that ...
Respiratory Devices·35 affected·Oct 7, 2019
CriticalFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Module E-sCAiOV
Respiratory Devices·37 affected·Sep 27, 2019
CriticalFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Module E-sCAiO
Respiratory Devices·161 affected·Sep 27, 2019
CriticalFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Module E-sCAiOVE
Respiratory Devices·14 affected·Sep 27, 2019
High RiskFDA
Respironics California, Llc
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
Respiratory Devices·2,851 affected·Sep 11, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·25,840 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·486 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·6,790 affected·Aug 15, 2019
High RiskFDA
Western / Scott Fetzer Company
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended...
Respiratory Devices·143,164 affected·Aug 15, 2019
CriticalFDA
Teleflex-morrisville
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Respiratory Devices·9,312 affected·Jun 14, 2019
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Respiratory Devices·16 affected·Jun 14, 2019
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold onl...
Respiratory Devices·123 affected·Jun 14, 2019
High RiskFDA
Xhale Assurance, Inc.
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for s...
Respiratory Devices·701,272 affected·May 8, 2019
High RiskFDA
Sentec Ag
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive mon...
Respiratory Devices·22 affected·May 2, 2019
High RiskFDA
Sentec Ag
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tens...
Respiratory Devices·198 affected·May 2, 2019
High RiskFDA
Sentec Ag
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive mon...
Respiratory Devices·10 affected·May 2, 2019