Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for th...
Medical Devices·69,693 affected·May 12, 2016
High RiskFDA
Medline Industries Inc
Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
Medical Devices·903 affected·May 11, 2016
High RiskFDA
Synthes (usa) Products Llc
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are n...
Medical Devices·2,098 affected·May 11, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Medical Devices·74 affected·May 9, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ Liat¿ Analyzer
Medical Devices·2 affected·May 9, 2016
High RiskFDA
Best Theratronics Ltd.
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to...
Medical Devices·128 affected·May 6, 2016
High RiskFDA
Invivo Corporation
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Medical Devices·3 affected·May 6, 2016
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support an...
Medical Devices·770 affected·May 5, 2016
High RiskFDA
Ellipse A/s
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Medical Devices·14 affected·May 5, 2016
High RiskFDA
Ellipse A/s
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Medical Devices·25 affected·May 5, 2016
High RiskFDA
Teleflex Medical
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A ...
Medical Devices·6,390 affected·May 5, 2016
High RiskFDA
Brainlab Ag
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Medical Devices·27 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Medical Devices·50 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Medical Devices·50 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap...
Medical Devices·3,893 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 ...
Medical Devices·219 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threade...
Medical Devices·3,955 affected·May 4, 2016
High RiskFDA
Agfa Healthcare Corp.
DX-D600 - DXD Imaging Package
Medical Devices·81 affected·May 2, 2016
High RiskFDA
Staar Surgical Co.
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Medical Devices·2,612 affected·May 2, 2016
RecallFDA
Leica Biosystems Richmond Inc.
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquis...
Medical Devices·283 affected·May 2, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Medical Devices·150 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Medical Devices·57 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Medical Devices·276 affected·Apr 29, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Medical Devices·205 affected·Apr 29, 2016
High RiskFDA
Cmp Industries, Llc
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for ...
Medical Devices·77 affected·Apr 28, 2016
High RiskFDA
Greatbatch Medical
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, ...
Medical Devices·1,110 affected·Apr 26, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomograph...
Medical Devices·2 affected·Apr 25, 2016
High RiskFDA
Volcano Corporation
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Cor...
Medical Devices·5,875 affected·Apr 25, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomogra...
Medical Devices·1 affected·Apr 25, 2016
RecallFDA
Gsk Consumer Healthcare
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Medical Devices·1,440 affected·Apr 25, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Medical Devices·165 affected·Apr 25, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomogra...
Medical Devices·1 affected·Apr 25, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomogra...
Medical Devices·1 affected·Apr 25, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Medical Devices·165 affected·Apr 25, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Medical Devices·165 affected·Apr 25, 2016
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PE...
Medical Devices·3 affected·Apr 24, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) a...
Medical Devices·28 affected·Apr 22, 2016
High RiskFDA
Accriva Diagnostics Inc., Dba Itc, Dba Accumetrics
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Medical Devices·135 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tom...
Medical Devices·4 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (C...
Medical Devices·46 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and...
Medical Devices·51 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) a...
Medical Devices·25 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) a...
Medical Devices·3 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomograph...
Medical Devices·1 affected·Apr 22, 2016
High RiskFDA
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and ...
Medical Devices·138 affected·Apr 22, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomograph...
Medical Devices·0 affected·Apr 22, 2016