Category

Respiratory Devices Recalls

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

629 recalls
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
High RiskFDA
3b Medical, Inc.
React Health PHOENIX 5L Oxygen Concentrator
Respiratory Devices·2 affected·Feb 4, 2026
CriticalFDA
Medline Industries, Lp
Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit
Respiratory Devices·141,971 affected·Dec 24, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit...
Respiratory Devices·3,045 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,P...
Respiratory Devices·1,611,081 affected·Nov 21, 2025
CriticalFDA
Draeger, Inc.
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system ...
Respiratory Devices·2,050 affected·Nov 10, 2025
CriticalFDA
Draeger, Inc.
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system a...
Respiratory Devices·191,470 affected·Nov 10, 2025
CriticalFDA
Draeger, Inc.
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and ...
Respiratory Devices·14,420 affected·Nov 10, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable...
Respiratory Devices·13,934 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portabl...
Respiratory Devices·12,201 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patien...
Respiratory Devices·342 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monito...
Respiratory Devices·11,987 affected·Oct 24, 2025
High RiskFDA
Edan Diagnostics
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient...
Respiratory Devices·354 affected·Oct 24, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling ada...
Respiratory Devices·148 affected·Oct 20, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adap...
Respiratory Devices·54 affected·Oct 20, 2025
High RiskFDA
Philips Respironics, Inc.
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: ...
Respiratory Devices·56 affected·Oct 7, 2025
CriticalFDA
Percussionaire Corporation
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Val...
Respiratory Devices·59,160 affected·Sep 17, 2025
High RiskFDA
Medtronic Perfusion Systems
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Respiratory Devices·26 affected·Sep 12, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The At...
Respiratory Devices·530 affected·Sep 9, 2025
CriticalFDA
Draeger, Inc.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The ...
Respiratory Devices·223 affected·Sep 9, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Respiratory Devices·5 affected·Jul 30, 2025
CriticalFDA
Philips Respironics, Inc.
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Respiratory Devices·8 affected·Jun 30, 2025
CriticalFDA
Philips Respironics, Inc.
DreamStation Auto. Non-Continuous Ventilator.
Respiratory Devices·28 affected·Jun 30, 2025
CriticalFDA
Philips Respironics, Inc.
DreamStation Auto CPAP. Non-Continuous Ventilator.
Respiratory Devices·57 affected·Jun 30, 2025
CriticalFDA
Hamilton Medical Ag
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HA...
Respiratory Devices·2,560 affected·Jun 26, 2025
CriticalFDA
Maquet Critical Care Ab
Servo-u Ventilator System. Model Number: 6688600.
Respiratory Devices·874 affected·May 30, 2025
CriticalFDA
Maquet Critical Care Ab
Servo-n Ventilator System. Model Number: 6694800.
Respiratory Devices·7,688 affected·May 30, 2025
CriticalFDA
Covidien
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. N...
Respiratory Devices·4,842 affected·May 21, 2025
CriticalFDA
Philips Respironics, Inc.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A...
Respiratory Devices·6 affected·May 9, 2025
CriticalFDA
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Respiratory Devices·5,958 affected·May 9, 2025
CriticalFDA
Philips Respironics, Inc.
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. Bi...
Respiratory Devices·3 affected·May 9, 2025
High RiskFDA
Ohio Medical Corporation
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Respiratory Devices·36 affected·May 8, 2025
High RiskFDA
Biofire Diagnostics, Llc
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Respiratory Devices·30 affected·Apr 30, 2025
High RiskFDA
Abbott Molecular, Inc.
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase ch...
Respiratory Devices·1,447 affected·Apr 28, 2025
CriticalFDA
Medical Depot Inc.
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a ve...
Respiratory Devices·89,532 affected·Apr 11, 2025
CriticalFDA
Vyaire Medical
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Descri...
Respiratory Devices·1,895 affected·Apr 10, 2025
CriticalFDA
Draeger, Inc.
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Descripti...
Respiratory Devices·65,150 affected·Mar 12, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respirat...
Respiratory Devices·442,296 affected·Mar 4, 2025
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Respiratory Devices·37 affected·Mar 3, 2025
High RiskFDA
Microbiologics Inc
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control mat...
Respiratory Devices·28 affected·Feb 20, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal...
Respiratory Devices·498 affected·Feb 3, 2025
CriticalFDA
Olympus Corporation Of The Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2...
Respiratory Devices·454 affected·Jan 15, 2025
CriticalFDA
Percussionaire Corporation
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51...
Respiratory Devices·4,727 affected·Dec 23, 2024
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Respiratory Devices·187 affected·Dec 20, 2024