Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,606 total recalls
S4-1 Transducer Probe
Philips Ultrasound, Inc
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material t
Covidien LP
Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Abbott Medical
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorde
MEDLINE INDUSTRIES, LP - Northfield
Food Intolerance Test Large
GET TESTED INTERNATIONAL AB
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac
Elekta, Inc.
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA, INC.
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar
Kirwan Surgical Products, LLC
BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM
Biomet, Inc.
WAVES WCM Kidney Cassette Module
Waters Medical Systems LLC
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8
Becton Dickinson & Company
medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Smiths Medical ASD, Inc.
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 a
NeuMoDx Molecular Inc
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
ICU Medical, Inc.
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOG
MEDLINE INDUSTRIES, LP - Northfield
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v
Angiodynamics, Inc.
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60
Omnia Medical
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)
Baxter Healthcare Corporation
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers
Philips North America Llc
AV FISTULA , Model No UTAV77T
American Contract Systems Inc
Ultracell Wick with 80cc Collection Bag, 20/box
Beaver Visitec International, Inc.
HeartWare HVAD Implant Kit, REF 1104JP
Heartware, Inc.
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medtronic Sofamor Danek USA Inc
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Visionsense, Ltd.
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powere
SURGIFY MEDICAL OY
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYN
MEDLINE INDUSTRIES, LP - Northfield
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., R
Smiths Medical ASD, Inc.
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Co
THOR Photomedicine Ltd
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