Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Conmed Corporation
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm...
Medical Devices·12,653 affected·Feb 20, 2014
High RiskFDA
Gyrus Medical, Inc
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. S...
Medical Devices·856 affected·Feb 19, 2014
CriticalFDA
Hospira Inc.
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and ...
Medical Devices·26,765 affected·Feb 18, 2014
High RiskFDA
Remel Inc
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke...
Medical Devices·40 affected·Feb 18, 2014
RecallFDA
Technidata S.a.
TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument a...
Medical Devices·85 affected·Feb 17, 2014
High RiskFDA
Walkmed Infusion, Llc
Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusi...
Medical Devices·797 affected·Feb 17, 2014
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this corre...
Medical Devices·15 affected·Feb 14, 2014
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Medical Devices·251 affected·Feb 14, 2014
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ...
Medical Devices·36 affected·Feb 14, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enab...
Medical Devices·12 affected·Feb 13, 2014
High RiskFDA
Synthes, Inc.
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Medical Devices·20 affected·Feb 11, 2014
High RiskFDA
Ams Diagnostics, Llc
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Medical Devices·13 affected·Feb 11, 2014
High RiskFDA
Thermedx Llc
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid t...
Medical Devices·21 affected·Feb 10, 2014
High RiskFDA
Heraeus Kulzer, Llc.
BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar,...
Medical Devices·812 affected·Feb 10, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Zee Angiographic x-ray systems.
Medical Devices·9 affected·Feb 7, 2014
CriticalFDA
Baxter Healthcare Corp.
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master ...
Medical Devices·277,096 affected·Feb 7, 2014
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Medical Devices·19 affected·Feb 6, 2014
High RiskFDA
Fisher Scientific Co
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack F...
Medical Devices·7,430 affected·Feb 5, 2014
High RiskFDA
Synthes, Inc.
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology in...
Medical Devices·45 affected·Feb 5, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Medical Devices·19,596 affected·Feb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Medical Devices·317,796 affected·Feb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Medical Devices·3,460,672 affected·Feb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Medical Devices·100,008 affected·Feb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Medical Devices·34,752 affected·Feb 4, 2014
High RiskFDA
Innovative Sterlization Technologies Llc
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Medical Devices·2,104 affected·Feb 3, 2014
High RiskFDA
Carl Zeiss Meditec Ag
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Lase...
Medical Devices·1 affected·Feb 3, 2014
High RiskFDA
Altasource Llc Dba Meta Labs Llc
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and plea...
Medical Devices·155 affected·Feb 3, 2014
High RiskFDA
Hospira Inc.
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intrave...
Medical Devices·36,881 affected·Jan 31, 2014
High RiskFDA
Bock,otto,orthopedic Ind,inc
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704,...
Medical Devices·464 affected·Jan 31, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrog...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) an...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Synthes, Inc.
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to ...
Medical Devices·20,081 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is onl...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Implantech Associates Inc
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is...
Medical Devices·300 affected·Jan 29, 2014
High RiskFDA
Alterg, Incorporated
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Medical Devices·2,221 affected·Jan 28, 2014
High RiskFDA
Synthes, Inc.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifica...
Medical Devices·12 affected·Jan 27, 2014
High RiskFDA
Synthes, Inc.
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Medical Devices·1,132,096 affected·Jan 27, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Medical Devices·50 affected·Jan 27, 2014
High RiskFDA
Clarity Medical Systems Inc
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmi...
Medical Devices·166 affected·Jan 24, 2014
High RiskFDA
Hospira Inc.
Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial...
Medical Devices·11,555 affected·Jan 24, 2014
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The Nx...
Medical Devices·969 affected·Jan 24, 2014
High RiskFDA
Hospira Inc.
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion ...
Medical Devices·11,781 affected·Jan 24, 2014
High RiskFDA
Carefusion 303, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. Th...
Medical Devices·3,500,000 affected·Jan 22, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option...
Medical Devices·359 affected·Jan 20, 2014
High RiskFDA
Medical Information Technology, Inc.
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Medical Devices·737 affected·Jan 17, 2014
High RiskFDA
Deroyal Industries Inc
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Medical Devices·2,504 affected·Jan 16, 2014