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    EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.

    FDA Recall
    Open, Classified ·Elucent Medical Inc·Product code NEU·November 18, 2024

    Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

    FDA Recall
    Open, Classified ·Product code NLH·December 22, 2025

    Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.

    FDA Recall
    Open, Classified ·Medline Industries Inc·Product code LRO·April 30, 2021

    Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH

    FDA Recall
    Open, Classified ·Product code NLH·December 22, 2025

    Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code OUG·December 6, 2017

    Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

    FDA Recall
    Open, Classified ·Product code NLH·December 22, 2025

    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQP·September 17, 2018

    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

    FDA Recall
    Open, Classified ·Monarch Medical Technologies·Product code NDC·May 3, 2019

    The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return mail bag, and the operation manual. This device is used with cables and electrodes that are placed on skin in the treatment area, and allow an electrical micro-current to relieve pain. The device requires a prescription from a physician. It is programmed by an RS medical employee (or Account Manager) to the physician's specific treatment plan for each patient. The patient is given instructions on how to utilize the device (proper electrode placement). Powered MUSCLE Stimulation indications for use including: 1) Relax muscle spasm. 2) Prevention or retardation of disuse atrophy. 3) Maintain or increase range of motion. 4) Increase local blood circulation. 5) Re-educate muscle. 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. INTERFERENTIAL Stimulation indications for use including: 1) Relieve acute pain. 2) Relieve and manage chronic pain.

    FDA Recall
    Terminated ·International Rehabilitative Sciences, Inc.·Product code IPF·June 11, 2008

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    FDA Recall
    Terminated ·HeartWare Inc·Product code DSQ·May 16, 0013

    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FTD·June 4, 2024

    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KQM·June 4, 2024

    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FTD·June 4, 2024

    2008T HD SYS. W/O CDX BLUESTAR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T Hemodialysis System without CDX

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T HD SYS. CDX BLUESTAR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T Hemodialysis System w/Bibag

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T Hemodialysis SYS, with CDX

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T GEN 2 Bibag without CDX

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T HD SYS. CDX W/BIBAG BLUESTAR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023