Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Becton Dickinson & Company
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
Medical Devices·29,982,150 affected·Aug 30, 2018
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
Mitek Screw and Washer Depth Gauge, Product Code 219024
Medical Devices·401 affected·Aug 30, 2018
CriticalFDA
Data Innovations, Llc
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer...
Medical Devices·9 affected·Aug 29, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·867 affected·Aug 28, 2018
High RiskFDA
Hitachi Healthcare Americas Corp Informatics Division
VidiStar(TM) PACS & DICOM Viewer Software system
Medical Devices·12 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·832 affected·Aug 28, 2018
High RiskFDA
Abbott Laboratories, Inc
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used fo...
Medical Devices·99 affected·Aug 28, 2018
High RiskFDA
Stryker Gmbh
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pedi...
Medical Devices·1,355 affected·Aug 28, 2018
High RiskFDA
Vision Rt Ltd
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) s...
Medical Devices·690 affected·Aug 24, 2018
High RiskFDA
Trimed Inc.
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonst...
Medical Devices·5 affected·Aug 24, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of t...
Medical Devices·11,580 affected·Aug 22, 2018
High RiskFDA
Safe N Simple, Llc
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
Medical Devices·125 affected·Aug 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap ...
Medical Devices·3,246 affected·Aug 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the...
Medical Devices·6,180 affected·Aug 22, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for u...
Medical Devices·73 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·48 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us...
Medical Devices·452 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·102 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO I...
Medical Devices·1,517 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pist...
Medical Devices·74 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used ...
Medical Devices·378 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol g...
Medical Devices·17 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pi...
Medical Devices·42 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for us...
Medical Devices·169 affected·Aug 21, 2018
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Medical Devices·2 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as ...
Medical Devices·3 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Medical Devices·106 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·10 affected·Aug 21, 2018
High RiskFDA
Genicon, Inc.
Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as...
Medical Devices·106 affected·Aug 21, 2018
High RiskFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated f...
Medical Devices·241 affected·Aug 21, 2018
High RiskFDA
Varian Medical Systems
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision ra...
Medical Devices·4 affected·Aug 20, 2018
High RiskFDA
Nordicneurolab As
fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and present...
Medical Devices·163 affected·Aug 20, 2018
High RiskFDA
Agfa N.v.
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics ...
Medical Devices·108 affected·Aug 15, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO 15000 REFRIGERATED STORAGE MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO RACK INPUT MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
STREAMLAB CORE UNIT / LYNX WITH IOM
Medical Devices·186 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO INPUT/OUTPUT MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 9000
Medical Devices·186 affected·Aug 14, 2018
High RiskFDA
Tec Com Gmbh
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-...
Medical Devices·5 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Medical Devices·186 affected·Aug 14, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
APTIO RACK OUTPUT MODULE
Medical Devices·441 affected·Aug 14, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Medical Devices·150 affected·Aug 13, 2018
High RiskFDA
Stryker Spine
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devi...
Medical Devices·5 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
Medical Devices·24 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
Medical Devices·72 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Medical Devices·100 affected·Aug 13, 2018