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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 92 of 92 Results
Product: apex
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HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend ... 1 03/22/2024 Thoratec Corp.
Revolution Apex, Revolution CT with Apex Edition 2 04/05/2022 GE Healthcare, LLC
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT w... 2 11/24/2021 GE Healthcare, LLC
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition 2 02/17/2021 GE Healthcare, LLC
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul... 2 01/26/2021 OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modula... 2 01/26/2021 OMNIlife science Inc.
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modul... 2 01/26/2021 OMNIlife science Inc.
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: inte... 2 12/23/2020 B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: inte... 2 12/23/2020 B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: inte... 2 12/23/2020 B Braun Medical, Inc.
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac an... 2 12/22/2020 GE Healthcare, LLC
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is int... 2 10/29/2020 GE Healthcare, LLC
Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inqui... 2 09/24/2020 Irvine Biomedical Inc, a St. Jude Medical Co.
Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inqui... 2 09/24/2020 Irvine Biomedical Inc, a St. Jude Medical Co.
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the... 2 12/20/2019 GE Healthcare, LLC
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and A... 2 10/23/2019 GE Healthcare, LLC
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup ... 2 09/05/2019 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Ac... 2 09/05/2019 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup ... 2 09/05/2019 OMNIlife science Inc.
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a... 2 06/04/2019 OMNIlife science Inc.
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-1392... 2 07/25/2018 OMNIlife science Inc.
26-Lead Transfer Set for use with APEX® Compounding System, Product Catalog Number 2112550 2 07/03/2018 B. Braun Medical, Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is int... 2 03/19/2018 OMNIlife science Inc.
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal fil... 2 09/16/2016 Ormco/Sybronendo
Offset Femoral Alignment Guide 4mm x 6®; Product Code: KS 67024 Product Usage: The instrumentati... 2 08/24/2015 Omnilife Science Inc.
Offset Femoral Alignment Guide, 2mm x 6®; Product Code: KS 67022 Product Usage: The instrumentat... 2 08/24/2015 Omnilife Science Inc.
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Pr... 2 08/21/2015 Omnilife Science Inc.
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip ... 2 07/14/2015 Omnilife Science Inc.
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA 2 08/15/2014 Omnilife Science Inc.
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product ... 2 07/16/2014 Axcentria Pharmaceuticals, LLC
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The int... 2 03/13/2014 GE Healthcare, LLC
Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure... 2 11/18/2013 Synovis Surgical Innovations, Inc.
Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular recon... 2 11/18/2013 Synovis Surgical Innovations, Inc.
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: Th... 1 07/24/2013 GE Healthcare, LLC
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention ... 2 07/10/2013 Linvatec Corp. dba ConMed Linvatec
***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dis... 2 07/10/2013 Linvatec Corp. dba ConMed Linvatec
Elekta, Apex add-on Micro MLC, collimator for radiation therapy. 2 02/26/2013 Elekta, Inc.
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 28... 2 10/04/2012 Accuro Medical Product LLC
Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Kn... 2 09/13/2012 Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Kn... 2 09/13/2012 Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Kn... 2 09/13/2012 Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Kn... 2 09/13/2012 Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Kn... 2 09/13/2012 Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Kn... 2 09/13/2012 Omni Life Science
Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada... 2 01/14/2012 Sorin Group USA, Inc.
Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Grou... 2 01/14/2012 Sorin Group USA, Inc.
Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA,... 2 01/14/2012 Sorin Group USA, Inc.
Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc... 2 01/14/2012 Sorin Group USA, Inc.
Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group U... 2 01/14/2012 Sorin Group USA, Inc.
Apex HP PHisio SMART Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin G... 2 01/14/2012 Sorin Group USA, Inc.
GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the... 2 03/03/2011 GE Healthcare, LLC
PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) an... 2 09/21/2010 Synovis Surgical Inovation Div. of
Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Gle... 2 03/02/2010 Sybron Dental Specialties
GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software) 2 01/13/2010 General Electric Medical Systems Information Technology
Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD Product Code: H3-82243. Intended for use in ... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD Product Code: H3-82860. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD Product Code: H3-82859. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD Product Code: H3-82858. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD Product Code: H3-82857. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD Product Code: H3-82856. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD Product Code: H3-82855. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD Product Code: H3-82854. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD Product Code: H3-82853. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD Product Code: H3-82852. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD Product Code: H3-82851. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD Product Code: H3-82850. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD Product Code: H3-82849. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD Product Code: H3-82848. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD Product Code: H3-82847. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD Product Code: H3-82238. Intended for use in ... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD Product Code: H3-82239. Intended for use in ... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD Product Code: H3-82240. Intended for use in ... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD Product Code: H3-82241. Intended for use in ... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD Product Code: H3-82242. Intended for use in ... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD Product Code: H3-82844. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD Product Code: H3-82845. Intended f... 2 09/10/2009 Omni Life Science
Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD Product Code: H3-82846. Intended f... 2 09/10/2009 Omni Life Science
GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring. 2 06/01/2009 GE Healthcare
Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for ... 2 09/17/2008 Hologic, Inc.
Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the... 2 09/17/2008 Hologic, Inc.
Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for t... 2 09/17/2008 Hologic, Inc.
Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for t... 2 09/17/2008 Hologic, Inc.
Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the e... 2 09/17/2008 Hologic, Inc.
ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patie... 2 10/21/2006 Ge Healthcare
GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -T... 2 10/20/2006 Ge Healthcare
Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an is... 2 07/20/2004 GE Medical Systems Information Technologies
Apex Pilot Shaft 17.5mm 2 07/20/2004 Apex Surgical, LLC
Apex Pilot Shaft 13mm 2 07/20/2004 Apex Surgical, LLC
Apex Pilot Shaft 14.4mm 2 07/20/2004 Apex Surgical, LLC
Apex Pilot Shaft 16mm 2 07/20/2004 Apex Surgical, LLC
Apex Pilot Shaft, 10mm 2 07/20/2004 Apex Surgical, LLC
Apex Pilot Shaft, 11.5mm 2 07/20/2004 Apex Surgical, LLC
 
 
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