FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individual…
FDA Device · Class II · 2018-09-26 · Exactech - VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnost…
FDA Device · Class III · 2018-09-26 · Ortho Clinical Diagnostics - PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vi…
FDA Device · Class II · 2018-09-26 · Polymedco Polymedco Cancer Diagnostic Products - Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way sili…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Foley C…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Cathe…
FDA Device · Class II · 2018-09-26 · Degania Silicone - CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (p…
FDA Device · Class II · 2018-09-26 · Shinchang Medical - ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology cathete…
FDA Device · Class II · 2018-09-26 · Arrow International - AIRO Mobile CT System Model # MobiCT-32
FDA Device · Class II · 2018-09-26 · Mobius Imaging - 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
FDA Device · Class II · 2018-09-26 · Arrow International - CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Cathete…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
FDA Device · Class II · 2018-09-26 · Tecan Us - VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagn…
FDA Device · Class III · 2018-09-26 · Ortho Clinical Diagnostics - NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnos…
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Leica M525 F20 Surgical Microscope System
FDA Device · Class II · 2018-09-26 · Leica Microsystems - DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
FDA Device · Class I · 2018-09-26 · Pro Med Instruments - ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product…
FDA Device · Class II · 2018-09-26 · Fresenius Medical Care Renal Therapies Group - Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
FDA Device · Class II · 2018-09-26 · Zimmer Biomet - VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp
FDA Device · Class II · 2018-09-26 · Biomerieux - OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley C…
FDA Device · Class II · 2018-09-26 · Degania Silicone - 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
FDA Device · Class II · 2018-09-26 · Arrow International - ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
FDA Device · Class II · 2018-09-26 · Swissray Medical - DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal su…
FDA Device · Class I · 2018-09-26 · Pro Med Instruments - Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood gl…
FDA Device · Class II · 2018-09-26 · Medtronic - Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on…
FDA Device · Class III · 2018-09-26 · Smiths Medical Asd - OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley…
FDA Device · Class II · 2018-09-26 · Degania Silicone - PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic syste…
FDA Device · Class II · 2018-09-26 · Polymedco Polymedco Cancer Diagnostic Products - ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vit…
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
FDA Device · Class II · 2018-09-26 · Siemens Medical Solutions Usa - Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Cathe…
FDA Device · Class II · 2018-09-26 · Degania Silicone - sterEOS workstation
FDA Device · Class II · 2018-09-26 · Eos Imaging - Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Cathe…
FDA Device · Class II · 2018-09-26 · Degania Silicone - ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM
FDA Device · Class II · 2018-09-19 · Sps Sterilization - Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 260 mm, Item Number: 814409260
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
FDA Device · Class II · 2018-09-19 · Remel - Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 260 mm, Item Number: 814613260
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use…
FDA Device · Class II · 2018-09-19 · Beaver Visitec - Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 320 mm, Item Number: 814511320
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 400 mm, Item Number: 814609400
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 340 mm, Item Number: 814311340
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized
FDA Device · Class II · 2018-09-19 · Sps Sterilization - Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized
FDA Device · Class II · 2018-09-19 · Sps Sterilization - Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 440 mm, Item Number: 814409440
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF…
FDA Device · Class II · 2018-09-19 · Remel - Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM
FDA Device · Class II · 2018-09-19 · Sps Sterilization - Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 400 mm, Item Number: 814413400
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 260 mm, Item Number: 814511260
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm, Item Number: 814609320
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM
FDA Device · Class II · 2018-09-19 · Sps Sterilization - Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm, Item Number: 814313440
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 420 mm, Item Number: 814309420
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - remel THIOGLYCOLLATE MEDIUM, REF 05152
FDA Device · Class II · 2018-09-19 · Remel - Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized
FDA Device · Class II · 2018-09-19 · Sps Sterilization - Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial
FDA Device · Class II · 2018-09-19 · Diagnostica Stago - Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280
FDA Device · Class II · 2018-09-19 · Zimmer Biomet
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