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U.S. Department of Health and Human Services

Medical Device Recalls

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101 to 150 of 500 Results *
Product: ivi Recall Date to: 07/05/2014
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QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of a... 2 05/24/2013 Intel-GE Care Innovations LLC
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product ... 2 05/15/2013 Iris Diagnostics
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 ... 2 05/03/2013 Becton Dickinson & Co.
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 a... 1 04/26/2013 Newport Medical Instruments Inc
The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12... 2 04/25/2013 Alere San Diego, Inc.
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and... 2 04/23/2013 GE Healthcare, LLC
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The infor... 2 04/12/2013 Siemens Medical Solutions USA, Inc
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. ... 3 04/10/2013 Lighthouse For The Blind
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use... 1 03/02/2013 Ad-Tech Medical Instrument Corporation
Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and ... 2 02/13/2013 CHENICA INC.
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM... 2 02/04/2013 Zimmer, Inc.
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either... 2 02/04/2013 Zimmer, Inc.
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either ce... 2 02/04/2013 Zimmer, Inc.
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for eithe... 2 02/04/2013 Zimmer, Inc.
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for e... 2 02/04/2013 Zimmer, Inc.
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemen... 2 02/04/2013 Zimmer, Inc.
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, ... 2 02/04/2013 Zimmer, Inc.
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented o... 2 02/04/2013 Zimmer, Inc.
45® Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2... 2 01/30/2013 Greatbatch Medical
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coag... 2 01/17/2013 Quanta System, S.p.A.
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Di... 1 12/26/2012 GE Healthcare, LLC
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a requir... 1 12/14/2012 Bunnell, Inc.
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine periphe... 2 12/07/2012 Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Eng... 2 12/07/2012 Hospira Inc.
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination o... 2 12/03/2012 Sekisui Diagnostics Llc
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere,... 2 11/21/2012 Biomet, Inc.
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy... 2 11/21/2012 Zimmer, Inc.
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the ... 2 11/08/2012 Stryker Howmedica Osteonics Corp.
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a... 2 10/22/2012 Advanced Bionics Corporation
AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 Syste... 2 10/12/2012 Beckman Coulter Inc.
IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bo... 2 10/10/2012 Immunodiagnostics Systems Ltd
IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box ... 2 10/10/2012 Immunodiagnostics Systems Ltd
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged indi... 2 10/04/2012 C.R. Bard, Inc., Urological Division
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually... 2 10/02/2012 Cure Medical LLC
Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. ... 2 09/26/2012 Invacare Corporation
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutop... 2 09/24/2012 RAYSEARCH LABORATORIES AB
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activat... 2 09/20/2012 Sekisui Diagnostics Llc
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220... 2 09/17/2012 Bio-Rad Laboratories
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To det... 2 09/14/2012 RAYSEARCH LABORATORIES AB
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC... 2 09/13/2012 Capsule Tech Inc.
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD wi... 3 09/06/2012 Trek Diagnostic Systems
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, In... 2 09/06/2012 Becton Dickinson & Co.
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained N... 2 09/05/2012 Capintec Inc
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with ... 2 09/04/2012 Exactech, Inc.
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator ... 1 08/31/2012 Respironics California Inc
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly ... 2 08/29/2012 SRI Surgical
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak P... 1 08/28/2012 GE OEC Medical Systems, Inc
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomi... 2 08/22/2012 GE OEC Medical Systems, Inc
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integra... 2 08/22/2012 Siemens Healthcare Diagnostics, Inc.
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16... 2 08/22/2012 Philips Medical Systems (Cleveland) Inc

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