BEUDAMED
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    The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.

    FDA Recall
    Terminated ·Scion Cardio-Vascular, Inc.·Product code FGO·June 30, 2003

    Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code FGO·November 14, 2011

    SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

    FDA Recall
    Terminated ·Scion Cardio-Vascular, Inc.·Product code FGO·May 23, 2003

    First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include: Labeled with First Aid Only, Inc. Vancouver, WA: Recreational Sports First Aid, Item SM-134; Welder's First Aid Kit, Item 253-U; Vehicle First Aid Kit, Item 220-0; On-The-Road Auto First Aid, Item FAO-310; Auto First Aid Essentials, Item FAO-340; Auto First Aid Essentials, Item FDA-532; Auto First Aid Essentials, Item FDA-552; Vehicle First Aid Kit, Item 221-U; Outdoor First Aid Kit, Item FAO-410; Outdoor First Aid Kit, Item FAO-410 Outdoor First Aid Kit, Item FAO-420; Outdoor First Aid Kit, Item FAO-430; Outdoor First Aid Kit, Item FAO-440; First Aid & Survival Kit, Item FA-462; First Aid Kit, FAO-422-06; First Aid Kit, 403-PC; First Aid Response Kit, FA-504; All Purpose First Aid Kit, Item FAO-112; All Purpose First Aid Kit, Item FAO-122; All Purpose First Aid Kit, Item FAO-142; All Purpose First Aid Kit, Item FAO-432; All Purpose First Aid Kit, Item FAO-444; All Purpose First Aid Kit, Item FAO-452; First Aid Essentials, Item FAO-130; First Aid Essentials, Item FAO-132; First Aid Essentials, Item FAO-134; First Aid Essentials, Item FAO-422; First Aid Essentials, Item FAO-428; First Aid Essentials, Item FAO-432; First Aid Essentials, Item FAO-442; Refillable First Aid Kit, FAO-490C; Refillable First Aid Kit, FAO-490C; Brite Stock first aid kits (only labeled on shipping case as being manufactured by First Aid Only): Item FAO-130-BS; Item FAO-132-BS; Item FAO-134-BS; Manufactured by First Aid Only, Inc. Vancouver, WA. Distributed by Wholesale Merchandisers, Inc., Grand Rapids, MI 49544: Lake & Trail Outdoor First Aid Kit, Item MJR-420; Lake & Trail Outdoor First Aid Kit, Item MJR440; First aid kits labeled DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544: meijer First Aid Kit, Item MJR-130; meijer First Aid Kit, Item MJR-442; First Aid Kits labeled FIRST AID Exchange: General Purpose Home First Aid Kit, Item 2800; Auto First Aid Kit, Item 2825 First Aid Kit labeled Distributed by Medicine Shoppe International St. Louis, MO: All purpose First Aid Kit, Item FAO-132-MS First Aid Kit labeled Mfg. by First Aid Only, Inc. Vancouver, WA Ready Solutions: First Aid Kit, Item 90030 First Aid Kit labeled NORTHERN Safety Co., Inc.: First Aid Kit, Item FAO-442-NS First Aid Kit labeled Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30060: Grafco First Aid Kit, Item 1799-9133 and First Aid Kit labeled -Provided by MOTURIS LTD- Custom Kit, Item 9099

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·December 10, 2007

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 20, 2021

    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022

    OttLite Rechargeable UVC Disinfecting Wand

    FDA Recall
    Open, Classified ·Ottlite TEchnologies, Inc.·Product code RHP·November 17, 2022

    First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·December 10, 2007

    Access 2 Immunoassay Analyzer, Catalog Number 81600N

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 5, 2025

    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

    FDA Recall
    Terminated ·Hero Health·Product code NXB·July 2, 2021

    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·March 5, 2024

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 23, 2020

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEO·April 23, 2020

    Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEO·January 8, 2026

    CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU1 and Kit Number 11272CUK1

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code FBO·April 1, 2022

    ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FEO·July 7, 2022