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U.S. Department of Health and Human Services

Medical Device Recalls
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151 to 200 of 500 Results *
Product: ivi Recall Date to: 07/05/2014
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OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match inser... 2 08/21/2012 Exactech, Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is u... 2 08/08/2012 Abbott Point Of Care Inc.
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13.... 2 08/03/2012 SCC Soft Computer
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm ... 2 08/01/2012 GE OEC Medical Systems, Inc
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injecti... 2 07/25/2012 Hospira Inc.
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and ... 1 07/24/2012 GE OEC Medical Systems, Inc
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE ... 2 07/24/2012 Exactech, Inc.
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1... 2 07/24/2012 Exactech, Inc.
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides contin... 1 07/23/2012 Respironics, Inc.
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diag... 2 07/18/2012 GE OEC Medical Systems, Inc
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MO... 2 07/09/2012 Vital Signs Devices, a GE Healthcare Company
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. C... 2 06/27/2012 SALTER LABS
Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX L... 2 06/07/2012 Captiva Spine, Inc
Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable comp... 2 06/07/2012 Captiva Spine, Inc
Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product i... 2 06/07/2012 Captiva Spine, Inc
Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX L... 2 06/07/2012 Captiva Spine, Inc
Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is t... 2 06/05/2012 Invacare Corporation
Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classificatio... 3 06/05/2012 Intel-GE Care Innovations LLC
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog Number 60-951... 2 05/29/2012 ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520... 2 05/29/2012 ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 23 cm Shaft, Catalog Number 60-9521... 2 05/29/2012 ConMed Electrosurgery
Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog Number 60-9522... 2 05/29/2012 ConMed Electrosurgery
Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, U... 2 05/29/2012 ConMed Electrosurgery
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a whi... 2 05/25/2012 Water Pik, Inc.
HPBLUE: HARMONIC® Blue Hand Piece; HP054: HARMONIC® Hand Piece; Non-Sterile products are individuall... 2 05/25/2012 Ethicon Endo-Surgery Inc
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: ... 2 05/23/2012 Captiva Spine, Inc
The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - St... 2 05/18/2012 Ethicon Endo-Surgery Inc
QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE20040... 3 05/16/2012 Intel-GE Care Innovations LLC
Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 002000... 2 05/10/2012 Instrumentation Laboratory Co.
Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(T... 2 05/10/2012 Siemens Healthcare Diagnostics, Inc.
Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Ste... 3 05/10/2012 Biomet, Inc.
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***F... 3 05/10/2012 Diamedix Corporation
Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devic... 2 04/20/2012 Alere San Diego dba Biosite Innovacon Hemosense Inc
TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Clev... 2 04/13/2012 Scottcare Corporation
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 throu... 2 04/10/2012 Siemens Healthcare Diagnostics, Inc.
GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476, Distribu... 2 04/05/2012 Philips Medical Systems (Cleveland) Inc
GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Distributed by... 2 04/05/2012 Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workstation Computed Tomography X-Ray Systems, M/N 728260, Distributed by: Phili... 2 04/05/2012 Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: Philips M... 2 04/05/2012 Philips Medical Systems (Cleveland) Inc
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Gl... 2 04/02/2012 Lifescan Inc
Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the ... 2 03/23/2012 Medtronic Vascular, Inc.
Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay... 2 03/21/2012 Beckman Coulter Inc.
The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators a... 2 03/13/2012 Stryker Sustainability Solutions, Inc.
Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, component... 2 03/12/2012 Varian Medical Systems, Inc.
Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSo... 2 03/12/2012 Varian Medical Systems, Inc.
Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Varia... 2 03/02/2012 Integra LifeSciences Corp.
Product Brand Names: Triage® Drugs of Abuse Panel 8 Test Kit (K924476), Triage® Drugs of Abuse Pane... 2 03/01/2012 Alere San Diego
DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit f... 2 02/29/2012 Zeiss, Carl Inc
Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number... 2 02/22/2012 Alere San Diego
Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava St... 2 02/22/2012 Alere San Diego

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
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