BEUDAMED
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    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    FDA Recall
    Open, Classified ·Life Technologies Corporation·Product code PFF·February 7, 2024

    ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code EOQ·June 10, 2020

    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code EOQ·June 10, 2020

    Ion Endoluminal System, REF: 380748-65

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code EOQ·July 12, 2024

    myQA iON; Article Number: MQ10-000;

    FDA Recall
    Open, Classified ·IBA Dosimetry GmbH Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·April 1, 2025

    Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code EOQ·December 4, 2025

    Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

    FDA Recall
    Open, Classified ·Young Dental Manufacturing I, LLC·Product code EJR·May 13, 2024

    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

    FDA Recall
    Open, Classified ·Arthrex, Inc.·Product code HAB·August 27, 2018

    FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action).

    FDA Recall
    Open, Classified ·Ferno-Washington Inc·Product code FPO·October 7, 2022

    Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller

    FDA Recall
    Open, Classified ·Thoratec LLC·Product code DSQ·May 13, 2026

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    FDA Recall
    Open, Classified ·Covidien LLC·Product code OLW·July 26, 2018

    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

    FDA Recall
    Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·September 22, 2022

    BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·September 26, 2025

    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·June 26, 2024

    4500MD Triple Quad Mass Spectrometer, Part Number 5032522

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    Citrine Triple Quad Mass Spectrometer, Part Number 5063684

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    API3200MD Mass Spectrometer, Part Number 4466230

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    Citrine QTRAP Mass Spectrometer, Part Number 5063685

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55. 2. Cardiosave Rescue. Model Number: 0998-00-0800-83.

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·September 21, 2021

    Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P

    FDA Recall
    Open, Classified ·Product code MSD·March 15, 2024