Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 212 of 548
FDA Devices Moderate Jun 24, 2020
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use …
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Jun 24, 2020
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling…
Resource Optimization & Innovation LLC
FDA Devices Moderate Jun 24, 2020
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixa…
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixat…
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Abaxis Inc
FDA Devices Moderate Jun 24, 2020
BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for …
Angiodynamics, Inc.
FDA Devices Moderate Jun 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended …
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Carefusion 2200 Inc
FDA Devices Moderate Jun 24, 2020
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual ener…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jun 24, 2020
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices inten…
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
GE Healthcare, LLC
FDA Devices Moderate Jun 24, 2020
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic o…
Angiodynamics, Inc.
FDA Devices Moderate Jun 24, 2020
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the …
Stryker GmbH
FDA Devices Moderate Jun 24, 2020
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Biomet
FDA Devices Moderate Jun 24, 2020
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Ma…
BIOSENSE WEBSTER
FDA Devices Moderate Jun 24, 2020
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardi…
Defibtech, LLC
FDA Devices Moderate Jun 24, 2020
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224…
Abbott Vascular
FDA Devices Moderate Jun 24, 2020
Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the t…
Stryker GmbH
FDA Devices Moderate Jun 17, 2020
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Qiagen Sciences LLC
FDA Devices Moderate Jun 17, 2020
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device i…
Ormco/Sybronendo
FDA Devices Moderate Jun 17, 2020
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative mea…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 17, 2020
Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol g…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 7133194…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2020
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic Navigation, Inc.
FDA Devices Moderate Jun 17, 2020
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotact…
Elekta, Inc.
FDA Devices Moderate Jun 17, 2020
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 1…
Alcon Research LLC
FDA Devices Moderate Jun 17, 2020
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimall…
Intuitive Surgical, Inc.
FDA Devices Moderate Jun 17, 2020
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer t…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jun 17, 2020
Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol g…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FA…
Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate Jun 17, 2020
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer …
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tr…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixa…
Biomet
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 7133…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2020
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer tr…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determinatio…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 17, 2020
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabi…
Biomet
FDA Devices Moderate Jun 17, 2020
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02),…
Philips North America, LLC
FDA Devices Moderate Jun 17, 2020
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./…
BioFire Diagnostics, LLC
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 7…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2020
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diag…
Canon Medical System, USA, INC.
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation a…
Biomet
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary in…
Biomet
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fix…
Biomet
FDA Devices Moderate Jun 17, 2020
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixa…
Biomet
FDA Devices Moderate Jun 17, 2020
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (includi…
Eizo Corporation
FDA Devices Moderate Jun 17, 2020
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody…
Acuity Surgical Devices, LLC
FDA Devices Moderate Jun 17, 2020
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and…
Eizo Corporation
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixatio…
Biomet