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    Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·January 8, 2010

    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code NOP·October 3, 2012

    Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag.

    FDA Recall
    Terminated ·Action Products Incorporated·Product code KNO·May 14, 2002

    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

    FDA Recall
    Terminated ·Action Products Incorporated·Product code KNO·February 2, 2004

    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.

    FDA Recall
    Terminated ·Merits Holdings Co. dba Merits Health Products, Inc.·Product code KNO·March 2, 2020

    Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTR·June 8, 2010

    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

    AUTION HYBRID AU-4050

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code KQO·May 3, 2019

    eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.

    FDA Recall
    Terminated ·Philips Visicu·Product code DRG·March 10, 2016

    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KOH·April 15, 2021

    Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CFN·July 12, 2023

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·May 4, 2023

    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OHD·April 15, 2021

    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.

    FDA Recall
    Open, Classified ·Kico Knee Innovation Company·Product code SBF·September 19, 2025

    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·April 4, 2023

    Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code MWS·October 31, 2023

    Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HNO·June 8, 2007

    CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.

    FDA Recall
    Terminated ·Invacare Corporation·Product code INO·June 18, 2013

    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.

    FDA Recall
    Terminated ·Med-logics Inc·Product code HNO·January 13, 2015