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    Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code EOQ·October 23, 2020

    Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty

    FDA Recall
    Terminated ·Product code JDI·January 11, 2016

    HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

    FDA Recall
    Terminated ·Philips North America LLC·Product code MKJ·November 23, 2018

    iPico Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Perfector Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    Ion Magnum Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    IELLIOS Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Arasys Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

    FDA Recall
    Terminated ·Vision-Sciences, Inc.·Product code EOB·December 27, 2011

    Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.

    FDA Recall
    Terminated ·Vision-Sciences, Inc.·Product code EOB·December 27, 2011

    AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.

    FDA Recall
    Terminated ·Amtryke LLC·Product code ION·March 27, 2015

    Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.

    FDA Recall
    Terminated ·North Coast Medical Inc 8100 Camino Arroyo·Product code ION·July 11, 2011

    IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003

    i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CHL·February 23, 2009

    FEM HD ION (various sizes)

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·October 11, 2013

    Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    FDA Recall
    Terminated ·Therasage, LLC.·Product code N/A·December 23, 2014

    FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    FDA Recall
    Terminated ·Therasage, LLC.·Product code N/A·December 23, 2014

    FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    FDA Recall
    Terminated ·Therasage, LLC.·Product code N/A·December 23, 2014

    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.

    FDA Recall
    Terminated ·Covidien LLC·Product code CBK·November 21, 2017

    Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center, the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network.

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MHX·January 25, 2019