BEUDAMED
    40 results · 21ms · Sources: EU EUDAMED, US FDA

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    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·July 7, 2025

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 24, 2024

    Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·April 8, 2024

    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

    VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·September 20, 2024

    Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·October 12, 2023

    TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #3333000000

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

    1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;

    FDA Recall
    Open, Classified ·UNIMAX MEDICAL SYSTEMS INC 8F-2, NO·Product code GCJ·June 25, 2024

    GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024