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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 50 of 500 Results *
Product: ivi Recall Date to: 07/05/2014
 
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ENDOPATH® XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4... 2 06/26/2015 Ethicon Endo-Surgery Inc
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantit... 2 06/26/2015 Abbott Laboratories
Pacific Hemostasis ® Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottl... 2 06/26/2015 Fisher Diagnostics, A Company of Fisher Scientific LLC
The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and... 2 06/26/2015 International Rehabilitative Sciences, Inc.
Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular... 2 06/26/2015 Terumo Cardiovascular Systems Corporation
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro ... 2 06/10/2014 Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measure... 2 06/09/2014 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM... 2 06/02/2014 Ortho-Clinical Diagnostics
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduct... 2 05/23/2014 Heraeus Kulzer, LLC.
Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per ca... 2 05/21/2014 Medline Industries Inc
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended... 2 05/16/2014 Siemens Medical Solutions USA, Inc
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for accept... 2 05/13/2014 Siemens Medical Solutions USA, Inc
Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44... 2 05/13/2014 Medline Industries Inc
Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC0... 2 05/12/2014 RM Temena GmbH
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number RE... 2 05/12/2014 RM Temena GmbH
Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the ... 2 05/10/2014 Zimmer, Inc.
SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory infor... 2 05/09/2014 SCC Soft Computer
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for... 2 04/24/2014 Philips Medical Systems, Inc.
Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU)... 2 04/24/2014 Stryker Instruments Div. of Stryker Corporation
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac i... 2 04/23/2014 GE Healthcare, LLC
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT... 1 04/14/2014 Newport Medical Instruments Inc
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805... 2 03/18/2014 Siemens Medical Solutions USA, Inc
Product Brand Name(s): Alere Triage® TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56... 2 03/17/2014 Alere San Diego, Inc.
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titaniu... 2 03/11/2014 Synthes, Inc.
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilat... 1 03/06/2014 Phillips Respironics, Inc.
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's R... 2 03/04/2014 Mako Surgical Corporation
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containin... 2 02/24/2014 NxStage Medical, Inc.
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN sy... 2 02/20/2014 Synthes, Inc.
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discover... 2 02/14/2014 GE Healthcare, LLC
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; ... 2 02/12/2014 Stryker Howmedica Osteonics Corp.
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be ... 2 02/06/2014 ITC-Nexus Dx
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gain... 2 02/03/2014 Exactech, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile,... 2 02/03/2014 CareFusion 303, Inc.
25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per ... 2 01/30/2014 Synergetics Inc
27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. P... 2 01/30/2014 Synergetics Inc
Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ... 2 01/30/2014 Synergetics Inc
Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12... 2 01/30/2014 Synergetics Inc
The Centricity Laboratory System is intended to be an information system designed to support the cli... 3 01/29/2014 GE Healthcare It
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging... 2 01/14/2014 GE Healthcare It
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen D... 2 01/09/2014 Alere San Diego, Inc.
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Dist... 2 01/08/2014 Invacare Corporation
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clin... 2 01/03/2014 Siemens Healthcare Diagnostics, Inc.
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clini... 2 01/03/2014 Siemens Healthcare Diagnostics, Inc.
The Centricity Laboratory System is intended to be an information system designed to support the cli... 2 01/02/2014 GE Healthcare It
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of t... 2 12/31/2013 Stryker Medical Division of Stryker Corporation
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg uni... 2 12/31/2013 Stryker Medical Division of Stryker Corporation
McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). 2 12/20/2013 Mckesson Information Solutions LLC
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology syste... 2 12/09/2013 Omnyx Llc
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a pr... 2 12/04/2013 Abbott Point Of Care Inc.
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multi... 2 12/03/2013 Siemens Healthcare Diagnostics, Inc.

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