Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Respiratory Devices·1,412 affected·Mar 1, 2023
High RiskFDA
Maquet Medical Systems Usa
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. ...
Respiratory Devices·10,587 affected·Feb 13, 2023
CriticalFDA
Philips Respironics, Inc.
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used ...
Respiratory Devices·1,233 affected·Feb 10, 2023
CriticalFDA
Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Respiratory Devices·8 affected·Jan 25, 2023
High RiskFDA
Western/scott Fetzer Company
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System ...
Respiratory Devices·24,287 affected·Jan 3, 2023
High RiskFDA
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB81...
Respiratory Devices·40,498 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Respiratory Devices·2,937 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. ...
Respiratory Devices·90,220 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Respiratory Devices·4,462 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB81...
Respiratory Devices·63,278 affected·Dec 12, 2022
High RiskFDA
Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Respiratory Devices·1,340 affected·Dec 12, 2022
CriticalFDA
Philips Respironics, Inc.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260,...
Respiratory Devices·20,807 affected·Dec 7, 2022
High RiskFDA
Devilbiss Healthcare Llc
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Respiratory Devices·1,004,315 affected·Nov 18, 2022
CriticalFDA
Caire, Inc.
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
Respiratory Devices·70 affected·Oct 10, 2022
CriticalFDA
Caire, Inc.
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
Respiratory Devices·3 affected·Oct 10, 2022
CriticalFDA
Caire, Inc.
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
Respiratory Devices·5 affected·Oct 10, 2022
High RiskFDA
Devilbiss Healthcare Llc
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Respiratory Devices·48 affected·Sep 19, 2022
CriticalFDA
Philips Respironics, Inc.
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and resp...
Respiratory Devices·146 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and...
Respiratory Devices·295 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea...
Respiratory Devices·34 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructiv...
Respiratory Devices·8 affected·Aug 26, 2022
High RiskFDA
Sentec Ag
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or...
Respiratory Devices·17,208 affected·Aug 22, 2022
High RiskFDA
Getinge Usa Sales Inc
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric a...
Respiratory Devices·102 affected·Jul 21, 2022
CriticalFDA
Getinge Usa Sales Inc
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u M...
Respiratory Devices·37,000 affected·Jul 20, 2022
CriticalFDA
Hamilton Medical Ag
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Respiratory Devices·358 affected·Jun 27, 2022
RecallFDA
Invacare Corporation
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Respiratory Devices·179 affected·Jun 10, 2022
High RiskFDA
Breas Medical, Inc.
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanic...
Respiratory Devices·1,113 affected·Jun 2, 2022
CriticalFDA
Getinge Usa Sales Inc
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product C...
Respiratory Devices·17 affected·May 2, 2022
High RiskFDA
Nihon Kohden America Inc
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients w...
Respiratory Devices·17 affected·Apr 29, 2022
CriticalFDA
Baxter Healthcare Corporation
In-Line ventilator adaptor
Respiratory Devices·9 affected·Apr 26, 2022
CriticalFDA
Baxter Healthcare Corporation
In-Line ventilator adaptor
Respiratory Devices·259 affected·Apr 26, 2022
CriticalFDA
Ge Healthcare, Llc
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilat...
Respiratory Devices·88,379 affected·Apr 18, 2022
High RiskFDA
Caire, Inc.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Respiratory Devices·2 affected·Mar 25, 2022
CriticalFDA
Medtronic Formerly Covidien
Puritan Bennett 980 Series Ventilator
Respiratory Devices·18,508 affected·Mar 25, 2022
High RiskFDA
Breas Medical, Inc.
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Respiratory Devices·707 affected·Mar 21, 2022
CriticalFDA
Respironics California, Llc
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
Respiratory Devices·0 affected·Feb 28, 2022
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Respiratory Devices·12,145 affected·Feb 28, 2022
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 107671...
Respiratory Devices·87,138 affected·Feb 28, 2022
High RiskFDA
Draeger Medical, Inc.
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog N...
Respiratory Devices·24,337 affected·Feb 14, 2022
High RiskFDA
Draeger Medical, Inc.
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 ...
Respiratory Devices·13,687 affected·Feb 14, 2022
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator Part Number 1138747
Respiratory Devices·294 affected·Jan 24, 2022
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053617
Respiratory Devices·16 affected·Jan 24, 2022
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent p...
Respiratory Devices·473 affected·Dec 22, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or int...
Respiratory Devices·205 affected·Dec 22, 2021
CriticalFDA
Vyaire Medical
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is...
Respiratory Devices·4,189 affected·Dec 20, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Respiratory Devices·14 affected·Nov 16, 2021
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Respiratory Devices·376 affected·Nov 8, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Respiratory Devices·278 affected·Nov 4, 2021