Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
Medical Devices·1,224 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
Medical Devices·55 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
Medical Devices·148 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
Medical Devices·14 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
Medical Devices·10 affected·Jan 9, 2017
High RiskFDA
Laerdal Medical Corporation
Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ...
Medical Devices·4,377 affected·Jan 8, 2017
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Medical Devices·74 affected·Jan 7, 2017
High RiskFDA
Hitachi Medical Systems America Inc
Hitachi Oasis MRI System - C-Spine Coil
Medical Devices·180 affected·Jan 6, 2017
High RiskFDA
The See Clear Company
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Cl...
Medical Devices·119,829 affected·Jan 6, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Medical Devices·345 affected·Jan 6, 2017
High RiskFDA
Haag-streit Usa Inc
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Medical Devices·163 affected·Jan 5, 2017
High RiskFDA
Endologix
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-8...
Medical Devices·832 affected·Jan 4, 2017
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item N...
Medical Devices·15,000 affected·Jan 4, 2017
High RiskFDA
Baxter Healthcare Corporation
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemo...
Medical Devices·256 affected·Jan 4, 2017
High RiskFDA
Seiler Instr. & Mfg. Co. Inc.
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Medical Devices·43 affected·Jan 1, 2017
High RiskFDA
Standex Intl Corp
Standex International Bakers Pride Microwave Ovens Model E300
Medical Devices·149 affected·Jan 1, 2017
High RiskFDA
Hospira Inc., A Pfizer Company
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as pare...
Medical Devices·62,847 affected·Dec 30, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·320 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable w...
Medical Devices·252 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable w...
Medical Devices·499 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·185 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·10 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable w...
Medical Devices·996 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·155 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·275 affected·Dec 28, 2016
High RiskFDA
Villa Sistemi Medicali S.p.a.
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy p...
Medical Devices·65 affected·Dec 27, 2016
High RiskFDA
Villa Sistemi Medicali S.p.a.
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General...
Medical Devices·65 affected·Dec 27, 2016
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9900 Elite. MDL Numbers: D148942, D155043
Medical Devices·26,256 affected·Dec 27, 2016
High RiskFDA
Villa Sistemi Medicali S.p.a.
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoros...
Medical Devices·65 affected·Dec 27, 2016
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9800. MDL Numbers: D222250, D141598
Medical Devices·26,256 affected·Dec 27, 2016
High RiskFDA
Roche Diagnostics Corporation
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for ana...
Medical Devices·5 affected·Dec 27, 2016
High RiskFDA
Endologix
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment...
Medical Devices·0 affected·Dec 27, 2016
High RiskFDA
Endologix
AFX Endovascular AAA System, Endoleak Type IIIA
Medical Devices·40,967 affected·Dec 27, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Medical Devices·107 affected·Dec 27, 2016
High RiskFDA
Endologix
AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with...
Medical Devices·40,967 affected·Dec 27, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavi...
Medical Devices·1 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the c...
Medical Devices·27 affected·Dec 23, 2016
High RiskFDA
Elekta, Inc.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan ra...
Medical Devices·433 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid ...
Medical Devices·2,933 affected·Dec 23, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X upgraded to XCT 882454
Medical Devices·0 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the ch...
Medical Devices·245 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the che...
Medical Devices·3 affected·Dec 23, 2016
High RiskFDA
Flower Orthopedics Corporation
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Medical Devices·0 affected·Dec 22, 2016
High RiskFDA
Tosoh Smd Inc
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware bet...
Medical Devices·34 affected·Dec 22, 2016
High RiskFDA
Agfa Healthcare Corp.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to docume...
Medical Devices·10 affected·Dec 22, 2016
High RiskFDA
Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Medical Devices·777 affected·Dec 22, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K@home Series : Hemodialysis System
Medical Devices·1,400 affected·Dec 21, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·279 affected·Dec 21, 2016