FDA recalls, September 2012: 541 published

156 different companies appear this month.

Risk classification: Class I: 250 · Class II: 261 · Class III: 30

Same month, other agencies:CPSC 14 recallsNHTSA 54 recalls

Recalls this month

DateProduct
September 26, 2012Protein Shots, Orange Sunshine Flavor, 2.9 fl oz (Responsible firm on label: Body Choice …F-2352-2012Protica, Inc
September 26, 2012ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack)…Z-2410-2012Siemens Healthcare Diagnostics, Inc
September 26, 2012Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filterZ-2418-2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
September 26, 2012HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead …Z-2379-2012Covidien LLC
September 26, 2012Thyme Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2314-2012San Francisco Herb & Natural Food Company
September 26, 2012Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. …Z-2413-2012Davol, Inc., Subs. C. R. Bard, Inc.
September 26, 2012Red Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the f…F-2148-2012American Licorice Co
September 26, 2012Somersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Sa…F-2331-2012Somersault Snack Co., LLC
September 26, 2012Spence & Co Ltd brand 8oz Smoked Salmon TrimF-2329-2012Spence & Co., Ltd.
September 26, 2012BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution …Z-2360-2012Custom Medical Specialties, Inc.
September 26, 2012The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to pre…Z-2381-2012Integra Life Sci.
September 26, 2012Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic …D-1682-2012Hospira Inc.
September 26, 2012ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparat…D-1674-2012Carefusion 213, Llc
September 26, 2012The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed…Z-2404-2012Philips Medical Systems (Cleveland) Inc
September 26, 2012Cut Tropical Mixed Fruit has the item #028-00165 and the UPC is 0 45009 00165 8. Metro…F-2362-2012Triple B Corporation - Charlie's Produce
September 26, 2012Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manu…D-1678-2012Sandoz Incorporated
September 26, 2012Cut Seasonal Fruit -Item # 028-00172 - Net Weight 20 oz UPC 045009 00172 6; Cut Season…F-2363-2012Triple B Corporation - Charlie's Produce
September 26, 2012Licorice Root, WHL; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2317-2012San Francisco Herb & Natural Food Company
September 26, 2012Peppermint Leaf Organic, Large Cut; Distributed by San Francisco Herb and Natural Food C…F-2322-2012San Francisco Herb & Natural Food Company
September 26, 2012Senna Pods Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2312-2012San Francisco Herb & Natural Food Company
September 26, 2012Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY …D-1683-2012Apace KY LLC
September 26, 2012Friendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Ca…F-2355-2012Friendly Ice Cream Corp.
September 26, 2012Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS…Z-2403-2012Roche Molecular Systems, Inc.
September 26, 2012Pau D'Arco Bark C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2309-2012San Francisco Herb & Natural Food Company
September 26, 2012Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully au…Z-2388-2012Instrumentation Laboratory Co.
September 26, 2012Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filterZ-2423-2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
September 26, 2012Organic Yerba Mate; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2321-2012San Francisco Herb & Natural Food Company
September 26, 2012Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filterZ-2419-2012Asahi Kasei Medical Co., Ltd., Okatomi Plant
September 26, 2012The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog n…Z-2398-2012Bio-Rad Laboratories
September 26, 2012Tea black, China T/B Cut; Distributed by San Francisco Herb and Natural Food Co. Fremon…F-2320-2012San Francisco Herb & Natural Food Company
September 26, 20120.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use…Z-2394-2012Amsino Medical USA
September 26, 20120.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use …Z-2393-2012Amsino Medical USA
September 26, 2012STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general sur…Z-2426-2012Steris Corporation
September 26, 2012Parsley Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2308-2012San Francisco Herb & Natural Food Company
September 26, 2012Fruit Bowls: 1) Seasonal Fruit Bowl (Walmart) Item # 028-06480***" and the UPC of the pac…F-2365-2012Triple B Corporation - Charlie's Produce
September 26, 2012Spearmint Leaf C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.F-2326-2012San Francisco Herb & Natural Food Company
September 26, 2012RED VINES Mixed Bites; Red and Black licorice mixed bites. UPC: 4136400288 and 413645127…F-2154-2012American Licorice Co
September 26, 2012Fruit Cup has Item # 028-07140, and the UPC 0 45009 07140 8. Label reads in part "*** …F-2366-2012Triple B Corporation - Charlie's Produce
September 26, 2012Olive Leaf Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremon…F-2306-2012San Francisco Herb & Natural Food Company
September 26, 2012ProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz …F-2349-2012Protica, Inc
September 26, 2012Fresh Fruit Product is labeled in part: "***Fresh Island Medley***1 LB (454g)***Best If …F-2333-2012World Food LLC.
September 26, 2012Delish Fruit Burst 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilm…F-2337-2012F & S Produce Co., Inc. (Site II)
September 26, 2012Precise Digital Accelerator Delivery of radiation to defined target volumesZ-2405-2012Elekta, Inc.
September 26, 2012The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1…Z-2378-2012RAYSEARCH LABORATORIES AB
September 26, 2012CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage …Z-2355-2012Custom Medical Specialties, Inc.
September 19, 2012Wawa apple peanut butter dipper Net Wt. 6.5 OZ (183g) Distributed by: Wawa, Inc Wawa, PA…F-2280-2012Missa Bay, LLC
September 19, 2012Garden-Fresh Tomato Mozzarella Salad Kit 4 lbs. 0 11596 55163 0F-2181-2012Garden-Fresh Foods, Inc.
September 19, 2012Dairy Fresh Baked Potato Salad, 5 lb., 0 70163 40659F-2239-2012Garden-Fresh Foods, Inc.
September 19, 2012Gills Onions were used in this product. The Tuna With Sun-Dried Cranberries & Lemon …F-2166-2012Ron Stockman Whole Foods
September 19, 2012Gills Onions were used in this product. The product listed below is prepared at Whole…F-2152-2012Ron Stockman Whole Foods

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