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    1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code HBE·September 5, 2024

    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QLT·December 21, 2022

    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50

    FDA Recall
    Open, Classified ·Micro Therapeutics, Inc.·Product code OUT·January 30, 2025

    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2

    FDA Recall
    Open, Classified ·Micro Therapeutics, Inc.·Product code OUT·January 30, 2025

    Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X

    FDA Recall
    Open, Classified ·MICROVENTION INC.·Product code OUT·September 5, 2025

    cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QLT·December 21, 2022

    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code QLT·April 28, 2023

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Recall
    Open, Classified ·Micro Therapeutics Inc·Product code OUT·July 13, 2021

    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QLT·December 21, 2022

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QLT·May 19, 2023

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics Inc·Product code QLT·September 5, 2024

    Pipeline Flex Embolization Device

    FDA Recall
    Open, Classified ·Micro Therapeutics Inc·Product code OUT·July 13, 2021

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QLT·May 13, 2022

    FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA, MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627

    FDA Recall
    Open, Classified ·MICROVENTION INC.·Product code OUT·June 7, 2023

    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code QCT·January 10, 2025

    The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. The 3.0MM Prec Neuro Match Head bur (5820-107-530) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial and craniofacial surgeries. These burs are sold as single use devices without their own IFU.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code HBE·June 28, 2023

    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code HBE·June 28, 2023

    Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

    FDA Recall
    Open, Classified ·Ethicon Endo-Surgery Inc·Product code GDW·April 22, 2025

    stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code HBE·June 28, 2023