Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips Medical Systems (cleveland) Inc
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used ...
Medical Devices·1,218 affected·Jan 31, 2017
High RiskFDA
Boston Scientific Corporation
AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that co...
Medical Devices·3,402 affected·Jan 31, 2017
High RiskFDA
Ergosafe Products, Llc (dba) Prism Medical
A-series lift - A625 Manual Part No. 324117. Prism Medical.
Medical Devices·76 affected·Jan 30, 2017
High RiskFDA
Phadia Us Inc
EliA Sample Diluent, Article number, 83-1023-01
Medical Devices·5,957 affected·Jan 30, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 1...
Medical Devices·90,000 affected·Jan 27, 2017
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conj...
Medical Devices·4,283 affected·Jan 27, 2017
High RiskFDA
Covidien Medtronic
Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use ...
Medical Devices·24,703 affected·Jan 26, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS f...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS f...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linea...
Medical Devices·35 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of lin...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The in...
Medical Devices·194 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator syste...
Medical Devices·35 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator syst...
Medical Devices·35 affected·Jan 25, 2017
High RiskFDA
Matrix Surgical Holdings, Llc
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Medical Devices·28 affected·Jan 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of lin...
Medical Devices·35 affected·Jan 25, 2017
RecallFDA
Integra Lifesciences Corp.
The UNI-CP System; Model Number: 330230SND.
Medical Devices·39 affected·Jan 25, 2017
High RiskFDA
Rti Surgical, Inc.
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Medical Devices·24 affected·Jan 23, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge LIS
Medical Devices·47 affected·Jan 23, 2017
High RiskFDA
Strata Skin Sciences, Inc.
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions incl...
Medical Devices·1,000 affected·Jan 23, 2017
High RiskFDA
Gibson Laboratories Llc
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pat...
Medical Devices·10 affected·Jan 20, 2017
High RiskFDA
Metrex Research, Llc.
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has ...
Medical Devices·960 affected·Jan 20, 2017
RecallFDA
Applied Medical Technology Inc
AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Medical Devices·110 affected·Jan 19, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cros...
Medical Devices·606 affected·Jan 18, 2017
High RiskFDA
Argon Medical Devices, Inc
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
Medical Devices·15 affected·Jan 18, 2017
High RiskFDA
Biomerieux Sa
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial ...
Medical Devices·7,160 affected·Jan 18, 2017
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and ana...
Medical Devices·741 affected·Jan 18, 2017
High RiskFDA
Argon Medical Devices, Inc
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting...
Medical Devices·772 affected·Jan 18, 2017
CriticalFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Medical Devices·66 affected·Jan 17, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare ...
Medical Devices·156 affected·Jan 17, 2017
CriticalFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
Medical Devices·61 affected·Jan 17, 2017
CriticalFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Medical Devices·145 affected·Jan 17, 2017
High RiskFDA
Pentax Of America Inc
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to...
Medical Devices·2,015 affected·Jan 17, 2017
High RiskFDA
Won Industry Co.
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massag...
Medical Devices·3 affected·Jan 13, 2017
High RiskFDA
Carestream Health Inc
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) ...
Medical Devices·1,403 affected·Jan 12, 2017
High RiskFDA
Vascular Solutions, Inc.
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intende...
Medical Devices·633 affected·Jan 12, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Medical Devices·4,500 affected·Jan 12, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Nasal Pack, part number PSS2186
Medical Devices·16 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Upper Torso Tray, part number PSS1554(B
Medical Devices·222 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
General Surgery Pack, part number PSS1380(A
Medical Devices·80 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Minor/General/Ortho Pack, part number PSS3258(B
Medical Devices·140 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Major Pack (1345), part number AMS6565
Medical Devices·39 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Ortho Pack, part number PSS3466(A
Medical Devices·84 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Orbitofacial Pack, part number AMS5850(A
Medical Devices·60 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Knee Pack, part number AMS4211
Medical Devices·150 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Transvaginal Pack, part number CMP1767
Medical Devices·650 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Major Kit, part number PHC1307(A
Medical Devices·85 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Total Hip Pack, part number PSS2956
Medical Devices·33 affected·Jan 11, 2017