BEUDAMED
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    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·May 27, 2021

    Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.

    FDA Recall
    Terminated ·Medical Industries America Inc·Product code CAF·September 7, 2004

    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

    FDA Enforcement
    Class III ·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 28, 2021

    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 30, 2019

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Recall
    Terminated ·Miami Fat Supply, Inc·Product code MUU·April 21, 2016

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Enforcement
    Class II ·Terminated·Miami Fat Supply, Inc·June 22, 2016

    Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·July 18, 2019

    AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Recall
    Terminated ·Product code MIH·December 27, 2016

    AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Recall
    Terminated ·Product code MIH·December 27, 2016

    GORE¿ EXCLUDER¿ AAA Endoprosthesis

    FDA Enforcement
    Class II ·Terminated·W. L. Gore & Associates Inc.·February 12, 2020

    AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Recall
    Terminated ·Product code MIH·December 27, 2016

    AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

    FDA Recall
    Terminated ·Product code MIH·December 27, 2016

    AFX Endovascular AAA System, Endoleak Type IIIA

    FDA Enforcement
    Class II ·Terminated·Endologix·January 25, 2017

    GORE EXCLUDER AAA Endoprosthesis

    FDA Recall
    Terminated ·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020