Category

Respiratory Devices Recalls

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

629 recalls
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Respiratory Devices·278 affected·Nov 4, 2021
CriticalFDA
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Respiratory Devices·278 affected·Nov 4, 2021
High RiskFDA
Draeger Medical, Inc.
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) u...
Respiratory Devices·2,169 affected·Sep 10, 2021
High RiskFDA
Nihon Kohden Orangemed, Inc
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is ...
Respiratory Devices·1,999 affected·Jul 20, 2021
RecallFDA
Smiths Medical Asd Inc.
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Respiratory Devices·2 affected·Jul 15, 2021
CriticalFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ven...
Respiratory Devices·60 affected·Jun 18, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Respiratory Devices·255,810 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Respiratory Devices·72,665 affected·Jun 14, 2021
High RiskFDA
Ventec Life Systems, Inc.
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro...
Respiratory Devices·1,934 affected·May 10, 2021
High RiskFDA
Covidien, Lp
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and resp...
Respiratory Devices·192,000 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patien...
Respiratory Devices·7,200 affected·Apr 29, 2021
High RiskFDA
Covidien, Lp
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care ...
Respiratory Devices·32,625 affected·Apr 29, 2021
High RiskFDA
Circulatory Technology Inc.
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Respiratory Devices·147 affected·Apr 27, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·2 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·34 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·18 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·12 affected·Apr 16, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Respiratory Devices·1 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
Respiratory Devices·2 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
Respiratory Devices·4 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
Respiratory Devices·4 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Respiratory Devices·10 affected·Apr 6, 2021
High RiskFDA
Smiths Medical Asd Inc.
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler...
Respiratory Devices·250 affected·Mar 31, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Respiratory Devices·5,430 affected·Mar 25, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reserv...
Respiratory Devices·14 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Ba...
Respiratory Devices·4 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) w...
Respiratory Devices·5 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurf...
Respiratory Devices·3 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is...
Respiratory Devices·7 affected·Feb 4, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance ...
Respiratory Devices·4 affected·Feb 4, 2021
High RiskFDA
Draeger Medical, Inc.
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conducti...
Respiratory Devices·25 affected·Jan 29, 2021
High RiskFDA
Getinge Group Logistics America, Llc
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients...
Respiratory Devices·144 affected·Jan 29, 2021
High RiskFDA
Draeger Medical, Inc.
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduct...
Respiratory Devices·150 affected·Jan 29, 2021
High RiskFDA
Lumiradx
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test ...
Respiratory Devices·3,274,272 affected·Jan 11, 2021
High RiskFDA
Respironics California, Llc
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used o...
Respiratory Devices·94 affected·Jan 6, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the ...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirator...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respirato...
Respiratory Devices·7,400,000 affected·Jan 4, 2021