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    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

    FDA Recall
    Terminated ·Sequal Technologies Inc·Product code CAW·October 1, 2009

    Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.

    FDA Recall
    Terminated ·System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140·Product code CAW·May 1, 2003

    HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.

    FDA Recall
    Terminated ·Invacare Corporation·Product code CAW·January 11, 2011

    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

    FDA Recall
    Terminated ·Caire, Inc.·Product code CAW·November 21, 2019

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·September 19, 2022

    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·March 9, 2023

    JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

    FDA Recall
    Open, Classified ·JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No·Product code CAW·December 9, 2024

    Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002

    FDA Recall
    Terminated ·Pacific Consolidated Industries LLC·Product code CAW·September 8, 2007

    NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.

    FDA Recall
    Terminated ·Inovo, Inc·Product code CAW·July 21, 2016

    Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.

    FDA Recall
    Terminated ·Carleton Life Support Systems Inc·Product code CAW·July 24, 2009

    OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.

    FDA Recall
    Terminated ·Oxysure Systems, Inc.·Product code CAW·June 12, 2015

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

    FDA Recall
    Completed ·Caire, Inc.·Product code CAW·October 4, 2024

    System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.

    FDA Recall
    Terminated ·System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140·Product code CAW·May 1, 2003

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    FDA Recall
    Terminated ·Oxus America, Inc.·Product code CAW·January 14, 2013

    SAROS Oxygen System Model 3000

    FDA Recall
    Terminated ·Caire, Inc.·Product code CAW·September 16, 2019

    DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

    FDA Recall
    Open, Classified ·DeVilbiss Healthcare LLC·Product code CAW·November 18, 2022

    iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code CAW·April 11, 2025

    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

    FDA Recall
    Open, Classified ·Ohio Medical Corporation·Product code CAW·May 8, 2025