Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inv...
Respiratory Devices·7,371 affected·Jun 4, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilato...
Respiratory Devices·104 affected·Jun 3, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module,...
Respiratory Devices·4,961 affected·May 23, 2014
High RiskFDA
Bacterin International, Inc.
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19...
Respiratory Devices·390 affected·May 15, 2014
High RiskFDA
William C. Domb, D.m.d., A Professional Corporation
Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per ho...
Respiratory Devices·16 affected·Apr 23, 2014
CriticalFDA
Hamilton Medical, Inc.
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for inten...
Respiratory Devices·1,128 affected·Apr 22, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Inte...
Respiratory Devices·5,765 affected·Apr 18, 2014
High RiskFDA
Teleflex Medical
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Respiratory Devices·2,600 affected·Apr 17, 2014
High RiskFDA
Ge Healthcare
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based ...
Respiratory Devices·723 affected·Apr 2, 2014
CriticalFDA
Del Mar Reynolds Medical, Ltd.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Respiratory Devices·16 affected·Mar 10, 2014
High RiskFDA
Teleflex Medical
Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobr...
Respiratory Devices·63,568 affected·Feb 28, 2014
CriticalFDA
Phillips Respironics, Inc.
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individual...
Respiratory Devices·572 affected·Feb 11, 2014
CriticalFDA
Draeger Medical Systems, Inc.
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ve...
Respiratory Devices·1,544 affected·Feb 7, 2014
High RiskFDA
Focus Diagnostics Inc
Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on t...
Respiratory Devices·1,052 affected·Jan 10, 2014
High RiskFDA
Abbott Point Of Care Inc.
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and...
Respiratory Devices·48 affected·Jan 1, 2014
High RiskFDA
On Site Gas Systems Inc.
On Site Gas Systems POGS 33C Portable Oxygen Generation System
Respiratory Devices·198 affected·Dec 19, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that m...
Respiratory Devices·237 affected·Dec 5, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended ...
Respiratory Devices·780 affected·Oct 10, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a control...
Respiratory Devices·12 affected·Oct 1, 2013
CriticalFDA
Ge Healthcare, Llc
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage...
Respiratory Devices·12 affected·Oct 1, 2013
High RiskFDA
Hamilton Medical, Inc.
HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medic...
Respiratory Devices·316 affected·Sep 26, 2013
CriticalFDA
Ge Healthcare, Llc
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in...
Respiratory Devices·59,721 affected·Sep 19, 2013
High RiskFDA
Integra Limited
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G,...
Respiratory Devices·79,887 affected·Sep 10, 2013
CriticalFDA
Carefusion 211 Inc Dba Carefusion
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. Thi...
Respiratory Devices·19,546 affected·Sep 5, 2013
CriticalFDA
Draeger Medical, Inc.
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to ...
Respiratory Devices·1,127 affected·Aug 14, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur med...
Respiratory Devices·503 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur m...
Respiratory Devices·42 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft...
Respiratory Devices·109 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur m...
Respiratory Devices·16 affected·Jun 11, 2013
CriticalFDA
Respironics California Inc
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 105...
Respiratory Devices·19,200 affected·Jun 4, 2013
High RiskFDA
Gyrus Acmi, Incorporated
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD,...
Respiratory Devices·100 affected·May 24, 2013
High RiskFDA
Ge Healthcare, Llc
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthe...
Respiratory Devices·800 affected·May 14, 2013
CriticalFDA
Nephron Pharmaceuticals Corp.
EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
Respiratory Devices·750 affected·Apr 30, 2013
CriticalFDA
Nephron Pharmaceuticals Corp.
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Respiratory Devices·604 affected·Apr 30, 2013
High RiskFDA
Embla System Llc
embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operat...
Respiratory Devices·519 affected·Apr 24, 2013
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICO...
Respiratory Devices·1,407 affected·Apr 22, 2013
High RiskFDA
Linde Gas North America Llc
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adult...
Respiratory Devices·52,264 affected·Mar 8, 2013