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U.S. Department of Health and Human Services

Medical Device Recalls

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Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with st... 2 11/12/2009 Organogenesis, Inc.
Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, dis... 2 11/20/2009 Boston Scientific Corporation
Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stapler 29 mm ... 2 11/23/2009 Surgical Devices/Covidien
Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loadi... 2 11/23/2009 Surgical Devices/Covidien
Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31... 2 01/07/2010 Hocoma AG
Aplio 50; SSA-700A; software version 5.5r002 2 03/19/2010 Toshiba American Medical Systems Inc
Aplio 80; SSA-770A; software version 5.5r002 2 03/19/2010 Toshiba American Medical Systems Inc
Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A340... 3 04/08/2010 Aplicare, Inc.
Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufacture... 2 04/27/2010 Elekta, Inc.
Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma K... 2 05/14/2010 Elekta, Inc.
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