Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Livanova Usa
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute...
Respiratory Devices·70 affected·Mar 13, 2018
High RiskFDA
Livanova Usa
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute ...
Respiratory Devices·42 affected·Mar 13, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the...
Respiratory Devices·739 affected·Mar 12, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to ...
Respiratory Devices·2 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to...
Respiratory Devices·16 affected·Mar 9, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operati...
Respiratory Devices·8 affected·Mar 1, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in ...
Respiratory Devices·27 affected·Mar 1, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operat...
Respiratory Devices·26 affected·Mar 1, 2018
High RiskFDA
Datex-ohmeda, Inc.
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanica...
Respiratory Devices·349 affected·Dec 8, 2017
High RiskFDA
Covidien Llc
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Vent...
Respiratory Devices·15,885 affected·Nov 21, 2017
High RiskFDA
Datascope Corporation
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Respiratory Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
Respiratory Devices·18 affected·Oct 19, 2017
High RiskFDA
Southmedic, Inc.
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery devic...
Respiratory Devices·8,871 affected·Oct 17, 2017
CriticalFDA
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anest...
Respiratory Devices·110 affected·Oct 11, 2017
High RiskFDA
Inovo, Inc
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Respiratory Devices·13,140 affected·Oct 9, 2017
High RiskFDA
Laerdal Medical Corporation
LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and t...
Respiratory Devices·204 affected·Aug 31, 2017
High RiskFDA
Nddd Medical Technologies, Inc.
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
Respiratory Devices·37 affected·Aug 15, 2017
High RiskFDA
Nddd Medical Technologies, Inc.
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Respiratory Devices·37 affected·Aug 15, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmona...
Respiratory Devices·10 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiop...
Respiratory Devices·27 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulm...
Respiratory Devices·8 affected·Jul 27, 2017
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device ...
Respiratory Devices·2,875 affected·Jul 14, 2017
High RiskFDA
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are ...
Respiratory Devices·1 affected·Jun 6, 2017
High RiskFDA
Natus Medical Incorporated
The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy ...
Respiratory Devices·275 affected·May 22, 2017
High RiskFDA
Convatec, Inc
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector...
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Produc...
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector ...
Respiratory Devices·0 affected·May 10, 2017
High RiskFDA
Convatec, Inc
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Respiratory Devices·816,709 affected·May 10, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage...
Respiratory Devices·198 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devic...
Respiratory Devices·18 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual ...
Respiratory Devices·30 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife ...
Respiratory Devices·4,640 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation dev...
Respiratory Devices·17,172 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The Ai...
Respiratory Devices·24 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devi...
Respiratory Devices·2,982 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation device...
Respiratory Devices·3,600 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The Air...
Respiratory Devices·720 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscit...
Respiratory Devices·150 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices...
Respiratory Devices·180 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation de...
Respiratory Devices·2,262 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The Ai...
Respiratory Devices·270 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLi...
Respiratory Devices·1,140 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manu...
Respiratory Devices·24 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resusci...
Respiratory Devices·8,100 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife...
Respiratory Devices·24 affected·Apr 27, 2017
CriticalFDA
Vyaire Medical
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are...
Respiratory Devices·797 affected·Apr 27, 2017