Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Ion Beam Applications S.a.
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Medical Devices·2 affected·Apr 11, 2016
High RiskFDA
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Medical Devices·81 affected·Apr 8, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by compute...
Medical Devices·424 affected·Apr 8, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (re...
Medical Devices·5,600 affected·Apr 6, 2016
High RiskFDA
Ceg Enterprises Llc
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manua...
Medical Devices·100,548 affected·Apr 5, 2016
High RiskFDA
Leica Microsystems, Inc.
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Medical Devices·90 affected·Apr 5, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Medical Devices·1,627 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software.
Medical Devices·217 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Medical Devices·333 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·17 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·29 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Medical Devices·78 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare.
Medical Devices·248 affected·Apr 4, 2016
CriticalFDA
B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used...
Medical Devices·40 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray...
Medical Devices·94 affected·Apr 1, 2016
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
Medical Devices·2,062 affected·Apr 1, 2016
CriticalFDA
B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ ca...
Medical Devices·90 affected·Apr 1, 2016
CriticalFDA
B Braun Medical Inc
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialy...
Medical Devices·147 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography...
Medical Devices·19 affected·Apr 1, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray s...
Medical Devices·18 affected·Apr 1, 2016
CriticalFDA
B Braun Medical Inc
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be...
Medical Devices·318 affected·Apr 1, 2016
CriticalFDA
B Braun Medical Inc
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodia...
Medical Devices·68 affected·Apr 1, 2016
High RiskFDA
Hologic, Inc
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Medical Devices·2,580 affected·Mar 31, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc.
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or...
Medical Devices·5,066 affected·Mar 31, 2016
High RiskFDA
Led Technologies, Llc
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a dev...
Medical Devices·32 affected·Mar 30, 2016
High RiskFDA
Teleflex Medical
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evac...
Medical Devices·12,124 affected·Mar 30, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H74914...
Medical Devices·47 affected·Mar 28, 2016
High RiskFDA
The Anspach Effort, Inc.
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (O...
Medical Devices·27 affected·Mar 28, 2016
High RiskFDA
Spacelabs Healthcare Inc
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data ...
Medical Devices·217 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy read...
Medical Devices·534 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge...
Medical Devices·1,627 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communicatio...
Medical Devices·537 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical informat...
Medical Devices·198 affected·Mar 28, 2016
High RiskFDA
The Anspach Effort, Inc.
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro...
Medical Devices·27 affected·Mar 28, 2016
High RiskFDA
Becton Dickinson & Co.
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20...
Medical Devices·88,300 affected·Mar 28, 2016
CriticalFDA
Monteris Medical Corp
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322...
Medical Devices·121 affected·Mar 25, 2016
High RiskFDA
Becton Dickinson & Company
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/i...
Medical Devices·176,000 affected·Mar 25, 2016
High RiskFDA
Hospira Inc.
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural i...
Medical Devices·1,490 affected·Mar 25, 2016
High RiskFDA
Abbott Laboratories
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Medical Devices·39,346 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X...
Medical Devices·203 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconst...
Medical Devices·8 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction...
Medical Devices·5 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer recons...
Medical Devices·17 affected·Mar 24, 2016
High RiskFDA
Teleflex Medical
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture lo...
Medical Devices·45 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X...
Medical Devices·318 affected·Mar 24, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruc...
Medical Devices·55 affected·Mar 24, 2016
High RiskFDA
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating...
Medical Devices·37 affected·Mar 24, 2016
RecallFDA
Acumedia Manufacturers, Inc.
Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on th...
Medical Devices·5 affected·Mar 23, 2016