Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 215 of 548
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary …
Thermo Fisher Scientific (Monterrey)
FDA Devices Moderate Jun 3, 2020
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Cardinal Health Inc.
FDA Devices Moderate Jun 3, 2020
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (…
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Jun 3, 2020
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the M…
Quest Medical, Inc.
FDA Devices Moderate Jun 3, 2020
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Applied Medical Resources Corp
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Heartware, Inc.
FDA Devices Moderate Jun 3, 2020
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS…
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Jun 3, 2020
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Cardinal Health Inc.
FDA Devices Moderate Jun 3, 2020
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use …
Boston Scientific Neuromodulation Corporation
FDA Devices Moderate Jun 3, 2020
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Later…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologist…
Radiometer Medical ApS
FDA Devices Moderate Jun 3, 2020
VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a…
C.A. Greiner & Sohne Gesellschaftmbh
FDA Devices Moderate Jun 3, 2020
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella,…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbo…
Beckman Coulter Inc.
FDA Devices Moderate Jun 3, 2020
Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
Applied Medical Resources Corp
FDA Devices Moderate Jun 3, 2020
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01,…
Inpeco S.A.
FDA Devices Moderate Jun 3, 2020
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diamete…
Spectranetics Corporation
FDA Devices Moderate Jun 3, 2020
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait tra…
MOTEK MEDICAL B.V.
FDA Devices Moderate Jun 3, 2020
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthe…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, …
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Applied Medical Resources Corp
FDA Devices Moderate Jun 3, 2020
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Nikon Metrology
FDA Devices Moderate Jun 3, 2020
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 M…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jun 3, 2020
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Cardinal Health Inc.
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Heartware, Inc.
FDA Devices Moderate Jun 3, 2020
JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instr…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 3, 2020
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Intuitive Surgical, Inc.
FDA Devices Moderate Jun 3, 2020
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189…
Biomet, Inc.
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Heartware, Inc.
FDA Devices Moderate Jun 3, 2020
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained…
Philips North America, LLC
FDA Devices Moderate Jun 3, 2020
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Applied Medical Resources Corp
FDA Devices Moderate Jun 3, 2020
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: C…
Clinical Innovations, LLC
FDA Devices Moderate Jun 3, 2020
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
CooperSurgical, Inc.
FDA Devices Moderate Jun 3, 2020
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solut…
Hologic, Inc
FDA Devices Moderate Jun 3, 2020
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A…
Philips North America, LLC
FDA Devices Critical Jun 3, 2020
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Medtronic Vascular Galway DBA Medtronic Ireland
FDA Devices Moderate Jun 3, 2020
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
GE Healthcare, LLC
FDA Devices Moderate Jun 3, 2020
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-1…
Inpeco S.A.
FDA Devices Moderate Jun 3, 2020
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous lea…
Boston Scientific Neuromodulation Corporation
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Heartware, Inc.
FDA Devices Moderate Jun 3, 2020
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Aceta…
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Biomet, Inc.
FDA Devices Moderate Jun 3, 2020
JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instr…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 3, 2020
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System wi…
Argon Medical Devices, Inc