BEUDAMED
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    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

    FDA Recall
    Terminated ·Product code REK·January 31, 2020

    Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.

    FDA Recall
    Terminated ·Cyberkinetics Neurotechnology Systems, Inc.·Product code GZL·February 4, 2009

    Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code MLD·February 6, 2006

    Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code MLD·February 6, 2006

    Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OES·April 21, 2026

    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K2054, Mat. No. 10464323

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFJ·October 11, 2018

    BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical Llc·Product code NJT·March 13, 2012

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Recall
    Terminated ·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    Revanesse Versa, PN40081

    FDA Recall
    Terminated ·Prollenium Medical Technologies Inc. 138 Industrial Pky N Aurora Canada·Product code LMH·November 15, 2018

    Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014

    ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code IKY·May 12, 2021

    Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the versatility of patient handling and transferring, which encourages ease of use and compliance. The design provides airflow to aid in patient comfort and pressure injury prevention.

    FDA Recall
    Terminated ·EHOB, Inc.·Product code IKY·January 19, 2020

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·January 24, 2014

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014

    Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #2710000027

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code IKY·May 12, 2021

    BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131

    FDA Recall
    Terminated ·BD Biosciences·Product code GKI·October 2, 2007

    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·March 7, 2014