Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - 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.
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical flu...
Respiratory Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - 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-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - 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-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - 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.
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the b...
Respiratory Devices·7,400,000 affected·Jan 4, 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
Laerdal Medical (suzhou) Co., Ltd.
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended f...
Respiratory Devices·5,035 affected·Dec 18, 2020
High RiskFDA
Sentec Ag
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of ...
Respiratory Devices·15 affected·Dec 10, 2020
CriticalFDA
Hill-rom Manufacturing, Inc.
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and ins...
Respiratory Devices·67 affected·Nov 12, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25...
Respiratory Devices·5,079 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Onl...
Respiratory Devices·6,000 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Respiratory Devices·16,000 affected·Nov 11, 2020
High RiskFDA
Westmed, Inc.
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx...
Respiratory Devices·600 affected·Nov 11, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironic...
Respiratory Devices·3,213 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·534 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·9,856 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·934 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·10,291 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·834 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·216 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironic...
Respiratory Devices·3 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·3,453 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·2,137 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respir...
Respiratory Devices·682 affected·Nov 2, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·934 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·10,441 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·2,144 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Respiratory Devices·38,990 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·9,863 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·46,313 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·534 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respir...
Respiratory Devices·3,887 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironi...
Respiratory Devices·481 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironic...
Respiratory Devices·3 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·835 affected·Oct 30, 2020
CriticalFDA
Invacare Corporation
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers:...
Respiratory Devices·384,767 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·3,453 affected·Oct 30, 2020
High RiskFDA
Biomeme, Inc.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplificat...
Respiratory Devices·105 affected·Oct 23, 2020
CriticalFDA
Covidien Llc
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who...
Respiratory Devices·23,329 affected·Oct 16, 2020
High RiskFDA
Getinge Group Logistics America, Llc
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it ...
Respiratory Devices·431 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the c...
Respiratory Devices·2 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support t...
Respiratory Devices·88 affected·Sep 17, 2020
High RiskFDA
Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Respiratory Devices·212 affected·Sep 14, 2020
CriticalFDA
Ab Ulax
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance h...
Respiratory Devices·1,484,100 affected·Sep 4, 2020
High RiskFDA
Battelle Memorial Institute
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirat...
Respiratory Devices·898 affected·Aug 13, 2020
High RiskFDA
Life Technologies Corporation
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time...
Respiratory Devices·0 affected·Aug 6, 2020
High RiskFDA
Carefusion 303, Inc.
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), ...
Respiratory Devices·680 affected·Aug 4, 2020