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    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·October 30, 2013

    i-STAT G3+ cartridge; List Number: 03P78-26;

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·May 6, 2026

    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 13, 2013

    i-STAT G3+ cartridge; List Number: 03P78-26;

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

    G3 Medical B.V.

    Importer
    🇳🇱 Netherlands

    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10 LNR G1 32MM 148-36-52 NV EHXL 10 LNR G2 36MM 148-36-53 NV EHXL 10 LNR G3 36MM 148-36-54 NV EHXL 10 LNR G4 36MM 148-36-55 NV EHXL 10 LNR G5 36MM 148-40-53 NV EHXL 10 LNR G3 40MM 148-40-54 NV EHXL 10 LNR G4 40MM 148-40-55 NV EHXL 10 LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·December 31, 2024

    Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10 LNR G1 32MM 148-36-52 NV EHXL 10 LNR G2 36MM 148-36-53 NV EHXL 10 LNR G3 36MM 148-36-54 NV EHXL 10 LNR G4 36MM 148-36-55 NV EHXL 10 LNR G5 36MM 148-40-53 NV EHXL 10 LNR G3 40MM 148-40-54 NV EHXL 10 LNR G4 40MM 148-40-55 NV EHXL 10 LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code OQI·December 31, 2024

    i-STAT EG6+ cartridge; List Number: 03P77-25;

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·May 6, 2026

    i-STAT EG7+ cartridge; List Number: 03P76-25;

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·May 6, 2026

    i-STAT EG6+ cartridge; List Number: 03P77-25;

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

    i-STAT EG7+ cartridge; List Number: 03P76-25;

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

    JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code JQW·August 2, 2017

    Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and 2023440. Cardiac Science, Bothell, WA 98021. Indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·October 12, 2009

    FLEXITOUCH PLUS SYSTEM

    FDA Adverse Event
    Injury ·TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL·Product code JOW·January 14, 2021

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·July 16, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·December 13, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·July 14, 2010

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 17, 2025

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·December 2, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·December 7, 2010