FDA recalls, June 2014: 284 published

127 different companies appear this month.

Risk classification: Class I: 41 · Class II: 226 · Class III: 17

Same month, other agencies:FSIS 9 recallsNHTSA 83 recalls

Recalls this month

DateProduct
June 11, 2014KrustaVita¿ Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); pac…F-1984-2014Royal Rye LLC
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated f…Z-1691-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstru…Z-1682-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: ost…Z-1720-2014Small Bone Innovations, Inc.
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for …Z-1690-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Lily Bloom's Kitchen Chocolate Coconut PoparoonsF1990-2014Lily Bloom's Kitchen
June 11, 2014Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant c…Z-1710-2014Leica Microsystems, Inc.
June 11, 2014The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Str…Z-1715-2014Stryker Instruments Div. of Stryker Corporation
June 11, 2014CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA …F-1988-2014Prep Enterprises Llc
June 11, 2014Greens+ Vegan Crisp Bars - Dark Chocolate Peanut Butter in 1.4 oz packages.F-1992-2014Orange Peel Enterprises, Inc.
June 11, 2014enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument …Z-1677-2014Ortho-Clinical Diagnostics
June 11, 2014Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port inf…Z-1703-2014Hospira Inc.
June 11, 2014Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems …Z-1721-2014Siemens Medical Solutions USA, Inc
June 11, 2014LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critic…Z-1702-2014Hospira Inc.
June 11, 2014Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) an…Z-1697-2014Integra LifeSciences Corporation
June 11, 2014Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products…Z-1713-2014Arrow International Inc
June 11, 2014LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow …D-1357-2014Golden State Medical Supply Inc.
June 11, 2014Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capa…Z-1714-2014Toshiba American Medical Systems Inc
June 11, 2014Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT…Z-1722-2014Philips Medical Systems (Cleveland) Inc
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated f…Z-1694-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for…Z-1696-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reco…Z-1683-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiograph…Z-1717-2014Siemens Medical Solutions USA, Inc
June 11, 2014Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60ba…F-2008-2014Rockman Company Usa Inc
June 11, 2014GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconst…D-1356-2014Pfizer Inc.
June 11, 2014The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker …Z-1716-2014Stryker Instruments Div. of Stryker Corporation
June 11, 2014Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and A…Z-1705-2014Spacelabs Healthcare Inc
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for …Z-1693-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (U…D-1359-2014Carefusion 2200 Inc
June 11, 2014Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size…Z-1708-2014C P Medical Inc.
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for…Z-1692-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2 oz. (57 g); Net wt…F-1986-2014E & M Corporation, Dba Noh Foods International Of Hawaii
June 11, 2014American Spoon¿ Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net…F-2007-2014American Spoon Foods, Inc.
June 11, 2014Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, S…Z-1706-2014GE Healthcare, LLC
June 11, 2014Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgica…Z-1718-2014Intuitive Surgical, Inc.
June 11, 2014Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and…Z-1704-2014Hospira Inc.
June 11, 2014CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marki…Z-1709-2014LAP of America Laser Applications, LLC
June 11, 2014Arena Ethnobotanicals and Kratom Pro, sizes: 1oz, 4oz, and 8oz.F-1989-2014Prep Enterprises Llc
June 11, 2014Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissu…Z-1699-2014Cochlear Americas Inc.
June 11, 2014MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is …Z-1719-2014ConMed Corporation
June 11, 2014Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, S…Z-1700-2014Hologic, Inc.
June 11, 2014Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the rec…Z-1684-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated f…Z-1688-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for u…Z-1686-2014Davol, Inc., Subs. C. R. Bard, Inc.
June 11, 2014Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL Sy…Z-1681-2014Synthes, Inc.
June 11, 2014Rockman (Brand) Skinless Peanut, 12 oz. Description: blanched skinless peanut. Pack…F-2009-2014Rockman Company Usa Inc
June 11, 2014REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Fact…F-1994-2014American Licorice Company
June 4, 2014ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic pe…Z-1672-2014Abbott Laboratories
June 4, 2014ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.Z-1659-2014Siemens Healthcare Diagnostics, Inc
June 4, 2014Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Ma…D-1355-2014Wockhardt Usa Inc.

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