Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of a...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endos...
Medical Devices·16 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an E...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endos...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an E...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of a...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an E...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of a...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endos...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex F...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Medical Devices·22 affected·May 27, 2015
High RiskFDA
Synthes, Inc.
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur...
Medical Devices·276 affected·May 27, 2015
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Medical Devices·72,773 affected·May 26, 2015
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. ...
Medical Devices·15,798 affected·May 26, 2015
High RiskFDA
Smiths Medical Asd, Inc.
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provid...
Medical Devices·4,426 affected·May 26, 2015
High RiskFDA
Exactech, Inc.
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to mani...
Medical Devices·2 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-...
Medical Devices·4 affected·May 21, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB ...
Medical Devices·1,856,619 affected·May 20, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab aut...
Medical Devices·1,941 affected·May 19, 2015
High RiskFDA
Remel Inc
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorga...
Medical Devices·143 affected·May 19, 2015
High RiskFDA
Coreva Health Science Llc
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated ...
Medical Devices·180,900 affected·May 18, 2015
High RiskFDA
Varian Medical Systems Inc
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Medical Devices·46 affected·May 18, 2015
High RiskFDA
Arthrocare Medical Corporation
EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coag...
Medical Devices·4,111 affected·May 15, 2015
High RiskFDA
Veridex, Llc
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Medical Devices·1,560 affected·May 15, 2015
High RiskFDA
Synthes, Inc.
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, os...
Medical Devices·54 affected·May 13, 2015
CriticalFDA
Ethicon Endo-surgery Inc
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system int...
Medical Devices·14 affected·May 13, 2015
High RiskFDA
Synthes, Inc.
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indica...
Medical Devices·1,495 affected·May 13, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitori...
Medical Devices·63 affected·May 13, 2015
RecallFDA
Bio-rad Laboratories, Inc.
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOL...
Medical Devices·20 affected·May 13, 2015
High RiskFDA
Advanced Back Technologies, Inc.
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Medical Devices·18 affected·May 13, 2015
High RiskFDA
Advanced Back Technologies, Inc.
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Medical Devices·36 affected·May 13, 2015
High RiskFDA
Vidacare Corporation
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corpora...
Medical Devices·2,104 affected·May 12, 2015
High RiskFDA
Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a ...
Medical Devices·44 affected·May 11, 2015
High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in ...
Medical Devices·22,250 affected·May 8, 2015
High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in ...
Medical Devices·12,020 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301C
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-303A
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301A
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Viewray Incorporated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiother...
Medical Devices·3 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c ...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi M...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/H...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in ser...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems fo...
Medical Devices·6,255 affected·May 7, 2015