FDA recalls, July 2012: 363 published

150 different companies appear this month.

Risk classification: Class I: 57 · Class II: 276 · Class III: 30

Same month, other agencies:CPSC 21 recallsNHTSA 64 recalls

Recalls this month

DateProduct
July 25, 2012Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It …Z-2019-2012Spacelabs Healthcare, Llc
July 25, 2012Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kunt…Z-2016-2012Stryker Howmedica Osteonics Corp.
July 25, 2012BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional re…Z-2031-2012Becton Dickinson & Co.
July 25, 2012Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED T…Z-2008-2012DeRoyal Industries Inc
July 25, 2012Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits…Z-2032-2012Becton Dickinson & Co.
July 25, 2012OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an a…Z-2025-2012GE OEC Medical Systems, Inc
July 25, 2012CareFusion EnVe Ventilator Designed for use on patients who require respiratory suppor…Z-2006-2012CareFusion 203, Inc.
July 25, 2012Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated t…Z-2037-2012Hitachi Medical Systems America Inc
July 25, 2012Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC,…D-1423-2012Bayer Healthcare, LLC
July 25, 2012SunOpta, Canadian Harvest Oat Fiber, Oat Fiber 300-33, Manufactured by SunOpta Ingredient…F-1769-2012SunOpta Ingredients Group (Corporate HQ)
July 25, 2012Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion sys…Z-2044-2012Terumo Cardiovascular Systems Corporation
July 25, 2012OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System des…Z-2026-2012GE OEC Medical Systems, Inc
July 25, 2012SP Standard Process, Cataplex C, Dietary Supplement, (Product # 1650 and 1655) , 90 & 36…F-1765-2012Standard Process, Inc.
July 25, 2012Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion Syste…Z-2050-2012Terumo Cardiovascular Systems Corporation
July 25, 2012MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made …Z-2018-2012Kimberly-Clark Corporation
July 25, 2012Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion Syst…Z-2049-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in Indi…D-1422-2012Pack Pharmaceuticals
July 25, 2012Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four…Z-2014-2012Etac Supply Center Ab
July 25, 2012Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured …D-1420-2012JHP Pharmaceuticals, LLC
July 25, 2012SP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement, 90 & 36…F-1764-2012Standard Process, Inc.
July 25, 2012Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-…Z-2033-2012Stryker Spine
July 25, 2012HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only…D-1417-2012Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
July 25, 2012Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug S…Z-2039-2012Alere San Diego, Inc.
July 25, 2012Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Sys…Z-2045-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For U…Z-2011-2012Stingray Surgical Products, LLC
July 25, 2012Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion S…Z-2051-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Truitt Brothers, Pacific Northwest Premium Navy Beans, net weight 15 oz. per metal can. …F-1770-2012Truitt Bros., Inc.
July 25, 2012Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blis…D-1424-2012Bayer Healthcare, LLC
July 25, 2012Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion Syste…Z-2052-2012Terumo Cardiovascular Systems Corporation
July 25, 2012EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; …Z-2023-2012EKOS Corporation
July 25, 2012Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion Sys…Z-2048-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48…Z-2041-2012Varian Medical Systems, Inc. Oncology Systems
July 25, 2012Old Fashioned Foods, Jalapeno Bean Dip, Ingredients: water, pinto beans, partially hydrog…F-1767-2012Old Fashioned Foods, Inc.
July 25, 2012Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfu…Z-2043-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. …D-1418-2012Meda Pharmaceuticals Inc.
July 25, 2012MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Hond…Z-2017-2012Kimberly-Clark Corporation
July 25, 2012OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient …Z-2027-2012GE OEC Medical Systems, Inc
July 25, 2012System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use f…Z-2020-2012Terumo Cardiovascular Systems Corporation
July 25, 2012SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage…Z-2030-2012Sigma
July 25, 2012Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion…Z-2046-2012Terumo Cardiovascular Systems Corporation
July 25, 2012GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacem…Z-2029-2012Gulf Fiberoptics, Inc.
July 25, 2012Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfu…Z-2042-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Per…Z-2010-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Per…Z-2009-2012Terumo Cardiovascular Systems Corporation
July 25, 2012Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Pres…Z-2012-2012Critical Diagnostics
July 25, 2012Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion…Z-2047-2012Terumo Cardiovascular Systems Corporation
July 25, 2012LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to …Z-2022-2012LMA North America Inc
July 25, 2012Abbott Acres, Meal Pals, Zesty Bean Dip, Ingredients: water, pinto beans, soybean oil, to…F-1768-2012Old Fashioned Foods, Inc.
July 25, 2012GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 20…Z-2015-2012GE Healthcare, LLC
July 25, 2012Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apar…Z-2028-2012Integra Limited

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