Category

Respiratory Devices Recalls

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

629 recalls
CriticalFDA
Baxter Healthcare Corporation
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Respiratory Devices·1 affected·Dec 20, 2024
CriticalFDA
Mercury Enterprises, Inc. Dba Mercury Medical
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 10...
Respiratory Devices·37,370 affected·Dec 10, 2024
High RiskFDA
3b Medical, Inc.
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Pro...
Respiratory Devices·5,010 affected·Nov 27, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Respiratory Devices·6,280 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Respiratory Devices·2,010 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Respiratory Devices·2,440 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Respiratory Devices·2,610 affected·Nov 24, 2024
High RiskFDA
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Respiratory Devices·5,120 affected·Nov 24, 2024
High RiskFDA
Olympus Corporation Of The Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.
Respiratory Devices·984 affected·Nov 19, 2024
High RiskFDA
Coopersurgical, Inc.
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An ele...
Respiratory Devices·37 affected·Nov 15, 2024
High RiskFDA
Coopersurgical, Inc.
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An elec...
Respiratory Devices·22 affected·Nov 15, 2024
High RiskFDA
Coopersurgical, Inc.
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description...
Respiratory Devices·34 affected·Nov 15, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult...
Respiratory Devices·9,999 affected·Oct 7, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B,...
Respiratory Devices·34,146 affected·Oct 7, 2024
CriticalFDA
Philips Respironics, Inc.
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at...
Respiratory Devices·804 affected·Oct 7, 2024
High RiskFDA
Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Respiratory Devices·26 affected·Oct 4, 2024
CriticalFDA
Percussionaire Corporation
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearan...
Respiratory Devices·43,830 affected·Sep 16, 2024
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4...
Respiratory Devices·10,957 affected·Sep 12, 2024
High RiskFDA
Luminex Molecular Diagnostics Inc
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Respiratory Devices·613 affected·Sep 5, 2024
CriticalFDA
Mercury Enterprises, Inc. Dba Mercury Medical
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Respiratory Devices·1,300 affected·Aug 30, 2024
CriticalFDA
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Respiratory Devices·2,523 affected·Aug 21, 2024
CriticalFDA
Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Respiratory Devices·50,460 affected·Aug 21, 2024
High RiskFDA
Cypress Medical Products Llc
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Respiratory Devices·15 affected·Aug 20, 2024
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warm...
Respiratory Devices·944 affected·Aug 7, 2024
High RiskFDA
Quantum Surgical Sas
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of...
Respiratory Devices·2 affected·Aug 5, 2024
High RiskFDA
Inspire Medical Systems Inc.
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Respiratory Devices·152 affected·Jul 31, 2024
CriticalFDA
Breas Medical, Inc.
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require ...
Respiratory Devices·8,298 affected·Jul 25, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Respiratory Devices·90,910 affected·Jul 16, 2024
CriticalFDA
Datex-ohmeda, Inc.
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pa...
Respiratory Devices·92 affected·Jul 12, 2024
CriticalFDA
Datex-ohmeda, Inc.
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are...
Respiratory Devices·0 affected·Jul 12, 2024
CriticalFDA
Datex-ohmeda, Inc.
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory suppor...
Respiratory Devices·12,559 affected·Jul 12, 2024
CriticalFDA
Datex-ohmeda, Inc.
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are t...
Respiratory Devices·15,739 affected·Jul 12, 2024
CriticalFDA
Datex-ohmeda, Inc.
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be...
Respiratory Devices·4,790 affected·Jul 12, 2024
CriticalFDA
Datex-ohmeda, Inc.
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general ...
Respiratory Devices·20,097 affected·Jul 12, 2024
CriticalFDA
Smiths Medical Asd Inc.
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Respiratory Devices·10,240 affected·May 31, 2024
CriticalFDA
Smiths Medical Asd Inc.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Respiratory Devices·11,244 affected·May 31, 2024
CriticalFDA
Baxter Healthcare Corporation
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20...
Respiratory Devices·2,510 affected·May 29, 2024
CriticalFDA
Zoll Medical Corporation
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: ...
Respiratory Devices·2,361 affected·Apr 30, 2024
High RiskFDA
Maquet Medical Systems Usa
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Respiratory Devices·148 affected·Apr 15, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary s...
Respiratory Devices·88 affected·Apr 8, 2024
CriticalFDA
Philips Respironics, Inc.
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R111...
Respiratory Devices·9,388 affected·Apr 1, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator, Part Number 1111178
Respiratory Devices·5,958 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111...
Respiratory Devices·6 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1...
Respiratory Devices·3 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·9,999 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·1,002 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·775 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·789 affected·Mar 19, 2024