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    WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.

    FDA Recall
    Terminated ·Telefelx Medical·Product code GEI·July 30, 2010

    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·March 15, 2019

    CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7IMAA

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·April 11, 2011

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·June 23, 2009

    MediBeads Neck Wrap, Item Number 34320

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Eye Compress, Item Number 2434

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Neck Wrap, Item Number 24322

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Stye Compress, Item Number 24352

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Heating Pad, Item Number 24002

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Sinus Compress, Item Number 24332

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Back Wrap, Item Number 24312

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Thermalon Sinus Compress (French), Item Number 24332F

    FDA Recall
    Open, Classified ·Bruder Healthcare Company, LLC·Product code IMA·February 21, 2024

    Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile; (6) Presource PBDS Cat. PN40CD806, Kit, Pedi C D, RWJ, Sterile; (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile; (8) Presource PBDS Cat. PN73APVD7, Kit, Neuro Spine Module, Sterile; (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile; (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile; (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile; (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile; (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile; (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile; (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile; (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile; (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile; (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile; (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile; (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile; (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile; (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile; (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile; (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile; (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile; (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile; (27) Presource Complex Spine Pack, Cat. SNE12NS388, Sterile; (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile; (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile; (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile; (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile; (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile; (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile; (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile; (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile; (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile; (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile; (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile; (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile; (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile; (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile; (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile; (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile; (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile; (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile; (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code OJG·August 16, 2023

    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

    FDA Recall
    Open, Classified ·LivaNova USA Inc·Product code LYJ·February 4, 2020