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    Halyard Closed Suction System for Adults, Turbo- cleaningClosedSuctionSystemforAdults,DoubleSwivelElbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DSE TRACH 14FR; g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR; h. HALYARD* TRACH CARE-72 DSE ENDO 10FR; i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK); j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR; k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR; l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR; n. HALYARD* 72 DSE TRACH CARE 12FR; o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN); p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR; q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN); r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR; s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR; t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR; u. HALYARD* TC-72 WET PAK DSE 14FR; v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE); x. HALYARD* TRACH CARE-72 DSE ENDO 12FR; y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE); z. HALYARD* TRACH CARE-72 DSE TRACH 12FR; aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR; ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE); ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM; ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR; ae. HALYARD* TRACH CARE-72 DSE ENDO 16FR; af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR; ag. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 16FR; ah. HALYARD* TRACH CARE-72 DSE MDI ENDO 16FR; ai. HALYARD* TRACH CARE-72 DSE 16FR; aj. HALYARD* TRACH CARE-72 WET PAK* DSE ENDO 12FR; ak. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN); al. HALYARD* TURBO-CLEANING 14FR DSE Endo;

    FDA Recall
    Terminated ·Halyard Health, Inc·Product code BSY·February 7, 2018

    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

    FDA Recall
    Open, Classified ·Abbott Laboratories, Inc·Product code MZA·February 3, 2022

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·September 23, 2022

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Recall
    Terminated ·Brainlab AG Olof-Palme-Strasse 9 Munich Germany·Product code HAW·April 22, 2013

    Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Recall
    Terminated ·Brainlab AG Kapellenstr. 12 Feldkirchen Germany·Product code LLZ·September 21, 2015

    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.

    FDA Recall
    Terminated ·Tripath Imaging, Inc.·Product code MKQ·December 8, 2011

    BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.

    FDA Recall
    Terminated ·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code MUJ·August 12, 2009

    Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

    FDA Recall
    Open, Classified ·Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom·Product code LDD·October 28, 2024

    Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0042.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·May 17, 2004

    Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens, 1 cartridge; manufactured for Disetronic Medical Systems AG. CJ-3401, Burgdorf, Switzerland; catalog number 150.0272.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LZG·May 17, 2004

    Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.

    FDA Recall
    Open, Classified ·Merge Healthcare, Inc.·Product code DQK·August 11, 2025

    Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007

    Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·October 2, 2007