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U.S. Department of Health and Human Services

Medical Device Recalls

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MULTIGENT Acetaminophen, List Number 2K99-20 2 09/18/2007 Abbott Laboratories Inc.
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.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended t... 2 08/02/2012 Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 2 07/09/2012 Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. T... 2 07/09/2012 Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests... 2 07/09/2012 Abbott Point Of Care Inc.
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for ... 2 07/09/2012 Abbott Point Of Care Inc.
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 de... 2 07/09/2012 Abbott Point Of Care Inc.
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sod... 2 07/09/2012 Abbott Point Of Care Inc.
i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part... 2 03/10/2011 Abbott Point Of Care Inc.
Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree... 2 12/10/2010 Abbott Point Of Care Inc.
i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 deg... 2 12/10/2010 Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The... 2 12/10/2010 Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 deg... 2 12/10/2010 Abbott Point Of Care Inc.
FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C... 2 12/10/2010 Abbott Point Of Care Inc.
i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37 degree C te... 2 12/10/2010 Abbott Point Of Care Inc.
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, ... 2 11/24/2010 Abbott Point of Care Inc.
i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540 2 11/03/2010 Abbott Point Of Care Inc.
i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540 2 11/03/2010 Abbott Point Of Care Inc.
i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540 2 11/03/2010 Abbott Point Of Care Inc.
i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ 2 07/13/2010 Abbott Point of Care Inc.
Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava St... 2 02/22/2012 Alere San Diego
Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number... 2 02/22/2012 Alere San Diego
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
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere IN... 1 01/03/2015 Alere San Diego, Inc.
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin ... 1 01/03/2015 Alere San Diego, 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.
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a flu... 2 10/10/2012 Alere San Diego, Inc.
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluoresce... 2 09/26/2012 Alere San Diego, Inc.
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a ... 2 07/19/2012 Alere San Diego, Inc.
Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 I... 2 11/21/2007 Applied Biotech Inc
Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product... 2 11/21/2007 Applied Biotech Inc
Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro... 3 12/13/2007 ARKRAY USA INC.
CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Dist... 2 12/04/2003 Baxter Healthcare Corp.
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporat... 3 03/05/2003 Baxter Healthcare Corp.
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1... 2 10/21/2019 Baxter Healthcare Corporation
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM Reagent when used in conjunction ... 2 09/25/2008 Beckman Coulter Inc
Synchron Systems Acetaminophen Reagent, part No. 472169. 2 07/20/2004 Beckman Coulter Inc
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label a... 2 09/12/2017 Beckman Coulter Inc.
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becto... 2 09/11/2013 Becton Dickinson & Company
Microtainer Safety flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade Length; 1.0mm b... 2 10/18/2007 Becton Dickinson & Company
Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Bl... 2 10/18/2007 Becton Dickinson & Company
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm... 2 10/18/2007 Becton Dickinson & Company
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Pr... 2 12/17/2020 Biomet, Inc.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infu... 2 10/09/2020 Biomet, Inc.
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM... 2 05/28/2020 Biomet, Inc.
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK... 3 06/11/2015 Biomet, Inc.
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma... 3 06/11/2015 Biomet, Inc.
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) 2 02/17/2015 Biomet, Inc.
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. 2 02/17/2015 Biomet, Inc.
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 18092... 2 12/17/2014 Biomet, Inc.
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, sem... 2 12/17/2014 Biomet, Inc.
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:... 2 06/19/2014 Biomet, Inc.
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110... 2 06/19/2014 Biomet, Inc.
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 2 12/13/2013 Biomet, Inc.
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical i... 2 03/08/2013 Biomet, Inc.
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere,... 2 11/21/2012 Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, sterile, REF PT... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, ... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, R... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, sterile, ... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, ... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, sterile, ... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, ... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented use, steril... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, sterile, REF... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use, sterile, RE... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring w/Plug, st... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring w/Plug, st... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 56 mm Size 24, w/Lock Ring w/Plug, st... 2 06/08/2011 Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring w/Plug, st... 2 06/08/2011 Biomet, Inc.

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