FDA recalls, October 2014: 384 published

172 different companies appear this month.

Risk classification: Class I: 73 · Class II: 283 · Class III: 28

Same month, other agencies:FSIS 13 recallsNHTSA 83 recalls

Recalls this month

DateProduct
October 8, 2014Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization…Z-2726-2014Instrumed International, Inc.
October 8, 2014Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics…Z-0002-2015Siemens Medical Solutions USA, Inc
October 8, 2014Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the S…Z-2719-2014St. Jude Medical, Inc.
October 8, 2014CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50Z-2717-2014KCI USA, Inc.
October 8, 2014Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are…Z-2735-2014Nanosphere, Inc.
October 8, 2014Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL …D-1610-2014Baxter Healthcare Corp.
October 8, 2014Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization…Z-2729-2014Instrumed International, Inc.
October 8, 2014VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For…Z-0007-2015Ortho-Clinical Diagnostics
October 8, 2014Goya Pinto Beans In Sauce prepared with Olive Oil, Cilantro &Tomato 15 oz. (425g)F-2531-2014Tradewind Foods de Puerto Rico Inc.
October 8, 2014BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g)F-2536-2014Bar Harbor Jam Company
October 8, 2014Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization…Z-2723-2014Instrumed International, Inc.
October 8, 2014Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the S…Z-2718-2014St. Jude Medical, Inc.
October 8, 2014Goya Small Red Beans Habichuelas Coloradas Pequenas 15.5 OZ (439g)F-2532-2014Tradewind Foods de Puerto Rico Inc.
October 8, 2014Basil Pesto Pasta packaged in a non-flex plastic tub, net wt 8 oz. A green sticker is pl…F-2539-2014TJs Place
October 8, 2014CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cu…D-0001-2015Cubist Pharmaceuticals, Inc.
October 8, 2014ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product…Z-2731-2014Intuitive Surgical, Inc.
October 8, 2014CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottl…D-1611-2014AbbVie Inc
October 8, 2014Philips Expression MR200 MRI Patient Monitoring System Model 866120Z-0001-2015Invivo Corporation
October 8, 2014eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch re…Z-0009-2015Gendex Corp
October 8, 2014Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle,…D-1616-2014Actavis Laboratories, FL, Inc.
October 8, 2014The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual al…Z-2713-2014Siemens Medical Solutions USA, Inc.
October 8, 2014Goya Black Bean Soup Prepared with Olive Oil, Bell Pepper & Onion 15 oz. (425g)F-2530-2014Tradewind Foods de Puerto Rico Inc.
October 8, 2014Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization…Z-2724-2014Instrumed International, Inc.
October 8, 2014Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization…Z-2728-2014Instrumed International, Inc.
October 8, 2014Goya Pink Beans In sauce prepared with Olive Oil, Cilantro & Onion 15 oz. (425g)F-2529-2014Tradewind Foods de Puerto Rico Inc.
October 8, 2014Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnos…Z-2720-2014Siemens Healthcare Diagnostics, Inc.
October 8, 2014ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended U…Z-0006-2015ELITech Clinical Systems SAS
October 8, 2014Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single…D-0002-2015Hospira Inc.
October 8, 2014The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography …Z-2711-2014Philips Medical Systems (Cleveland) Inc
October 8, 2014Goya Chick Peas Garbanzos 15.5 oz. (439g)F-2526-2014Tradewind Foods de Puerto Rico Inc.
October 8, 2014Goya Whole Green Peas Chicharos 15.5 oz (439g)F-2524-2014Tradewind Foods de Puerto Rico Inc.
October 8, 2014The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-…Z-2712-2014Siemens Medical Solutions USA, Inc.
October 8, 2014Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are…Z-2736-2014Nanosphere, Inc.
October 8, 2014Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscop…Z-0004-2015Siemens Medical Solutions USA, Inc
October 8, 2014SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administrat…Z-2738-2014Baxter Healthcare Corp.
October 8, 2014MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT…D-1614-2014Eugene Oregon, Inc.
October 8, 2014Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as …Z-0003-2015Siemens Medical Solutions USA, Inc
October 8, 2014All sterile drugs compounded between 2/21/14 and 2/24/14.D-0003-2015New England Home Therapies, Inc
October 8, 2014ADVIA Centaur XP Immunoassay System (including refurbished units), This system is int…Z-2716-2014Siemens Healthcare Diagnostics
October 8, 2014ADVIA Centaur Immunoassay System (including refurbished units), This system is intend…Z-2715-2014Siemens Healthcare Diagnostics
October 8, 2014The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicate…Z-2734-2014Baro-Therapies, Inc
October 8, 2014Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization…Z-2727-2014Instrumed International, Inc.
October 1, 2014Roots, Black Bean Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC…F-2497-2014Roots Organic Gourmet
October 1, 2014CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathi…Z-2689-2014Carefusion 2200 Inc
October 1, 20140.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#30…Z-2670-2014Centurion Medical Products Corporation
October 1, 201483" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave…Z-2621-2014ICU Medical, Inc.
October 1, 2014Roots, Roasted Garlic Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000016, …F-2493-2014Roots Organic Gourmet
October 1, 2014Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by …D-1609-2014Apotex Corp.
October 1, 2014eye-pak 7407 Tray Support Cover REF 8065740745Z-2694-2014Alcon Research, Ltd.
October 1, 2014Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Produc…Z-2708-2014Dako North America Inc.

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