FDA recalls, August 2013: 414 published

149 different companies appear this month.

Risk classification: Class I: 71 · Class II: 306 · Class III: 37

Same month, other agencies:CPSC 24 recallsNHTSA 75 recalls

Recalls this month

DateProduct
August 7, 2013Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distribu…Z-1827-2013Steritec Products Mfc. Co., Inc.
August 7, 2013GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device…Z-1833-2013GE Healthcare, LLC
August 7, 2013syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics s…Z-1859-2013Siemens Medical Solutions USA, Inc
August 7, 2013Penny's Garlic Hummus 12 oz has UPC 7 49404 83061 4; Harbor Greens Garlic Hummus 8 oz ha…F-1770-2013Hagee Foods Inc.
August 7, 2013Fisher's Homestyle Salads LLC***Gourmet Crab Cakes*** packaged in 6-piece (36 oz) and 12-…F-1759-2013Fisher's Homestyle Salads
August 7, 2013uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 D…Z-1831-2013Wako Life Sciences, Inc.
August 7, 2013Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor …Z-1815-2013Leica Microsystems, Inc.
August 7, 2013LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of…Z-1820-2013DePuy Orthopaedics, Inc.
August 7, 2013Vegetable tray 8 oz UPC 7 49404 30002 5; Ingredients: Carrot Sticks, Pretzels, Grapes, …F-1778-2013Hagee Foods Inc.
August 7, 2013OSKRI, Coconut Bar Dark Chocolate, Net Wt. 1.9 oz ( 53g), UPC 6 66016 30070 3. Ingred…F-1779-2013Oskri Corp.
August 7, 2013ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile…Z-1818-2013Sotera Wireless, Inc.
August 7, 2013Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Co…Z-1822-2013Steritec Products Mfc. Co., Inc.
August 7, 2013Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of ch…Z-1836-2013St. Jude Medical
August 7, 2013Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation …Z-1863-2013Acclarent, Inc.
August 7, 2013Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy hol…Z-1869-2013SpineFrontier, Inc.
August 7, 2013Vegetable tray 8 oz UPC 7 49404 98020 3; Ingredients: Carrot Sticks, Celery, Grape Toma…F-1777-2013Hagee Foods Inc.
August 7, 2013OSKRI, Almond Dark Chocolate Bars, Net Wt 1.9 oz (53g), UPC 6 66016 30042 0. Ingredien…F-1781-2013Oskri Corp.
August 7, 2013Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laborator…D-830-2013Torrent Pharma Inc
August 7, 2013WHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt…F-1783-2013Lipari Foods, Inc.
August 7, 2013Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tabl…D-822-2013Warner Chilcott US LLC
August 7, 2013Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation …Z-1861-2013Acclarent, Inc.
August 7, 2013Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufacture…Z-1837-2013Accelerated Care Plus Corporation
August 7, 2013OSKRI, Fig Dark Chocolate Bar, Net Wt 1.9 oz (53g) UPC 6 66016 30030 7. Ingredients: F…F-1780-2013Oskri Corp.
August 7, 2013Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. T…Z-1814-2013Picis Inc.
August 7, 2013Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation …Z-1860-2013Acclarent, Inc.
August 7, 2013Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whol…F-1746-2013Whole Foods Market Mid-Atlantic Kitchen
August 7, 2013DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL …D-831-2013Baxter Healthcare Corp.
August 7, 2013DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liqu…D-827-2013Procter & Gamble Co
August 7, 2013The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, dru…Z-1847-2013Hospira Inc.
August 7, 2013Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)Z-1813-2013HeartWare Inc
August 7, 2013El Campestre Brand Seafood Ranchero. Packaged in 2/5lbs white plastic buckets with lid a…F-1761-2013El Campestre
August 7, 2013EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam …Z-1824-2013Steritec Products Mfc. Co., Inc.
August 7, 2013Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277…F-1754-2013Church & Dwight Inc
August 7, 2013Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation …Z-1866-2013Acclarent, Inc.
August 7, 2013Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray systemZ-1848-2013Siemens Medical Solutions USA, Inc
August 7, 2013Fisher's Homestyle Salads LLC***Broccoli Cheese Soup*** packaged in 5 lb and 10 lb plasti…F-1757-2013Fisher's Homestyle Salads
August 7, 2013Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated fo…Z-1821-2013Synthes USA HQ, Inc.
August 7, 2013Harbor Greens Sun-Dried Tomato Hummus 8 oz has UPC 7 49404 80717 3; Tacoma Boys Sun-Dri…F-1776-2013Hagee Foods Inc.
August 7, 2013GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purp…Z-1849-2013GE Healthcare, LLC
August 7, 2013Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Dis…Z-1826-2013Steritec Products Mfc. Co., Inc.
August 7, 2013Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Co…Z-1823-2013Steritec Products Mfc. Co., Inc.
August 7, 2013Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by Vista…D-829-2013Actavis South Atlantic LLC
August 7, 2013Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation …Z-1865-2013Acclarent, Inc.
August 7, 2013Fisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb pl…F-1755-2013Fisher's Homestyle Salads
August 7, 2013Penny's Jalapeno Hummus 12 oz UPC 7 49404 91368 3; Harbor Greens Jalapeno Hummus 8 oz UP…F-1774-2013Hagee Foods Inc.
August 7, 2013AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyze…Z-1830-2013Tosoh Smd Inc
August 7, 2013GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics …Z-1846-2013Stryker Howmedica Osteonics Corp.
August 7, 2013BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog #…Z-1812-2013Becton Dickinson & Co.
August 7, 2013Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile…Z-1819-2013Custom Spine, Inc.
August 7, 2013ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intende…Z-1817-2013Sotera Wireless, Inc.

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