FDA recalls, August 2014: 374 published

129 different companies appear this month.

Risk classification: Class I: 36 · Class II: 316 · Class III: 22

Same month, other agencies:FSIS 6 recallsNHTSA 57 recalls

Recalls this month

DateProduct
August 27, 2014TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software v…Z-2239-2014TomoTherapy Incorporated
August 27, 2014Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component u…Z-2256-2014Ortho Development Corporation
August 20, 2014Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pou…Z-2201-2014Gambro Renal Products, Incorporated
August 20, 2014Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+…Z-2178-2014AGFA Healthcare Corp.
August 20, 2014Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plast…Z-2199-2014Gambro Renal Products, Incorporated
August 20, 2014BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process cont…Z-2233-2014BD Biosciences, Systems & Reagents
August 20, 2014Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)Z-2226-2014Zimmer, Inc.
August 20, 2014Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pou…Z-2196-2014Gambro Renal Products, Incorporated
August 20, 2014Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronical…Z-2235-2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
August 20, 2014Double Offset Rasp Handle, Left Hand NonsterileZ-2216-2014Zimmer, Inc.
August 20, 2014Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouche…Z-2203-2014Gambro Renal Products, Incorporated
August 20, 2014DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnos…Z-2175-2014AGFA Healthcare Corp.
August 20, 2014Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative ima…Z-2213-2014Brainlab AG
August 20, 2014Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundarie…Z-2181-2014Beevers Manufacturing & Supply, Inc.
August 20, 2014Double Offset Rasp Handle, Left Hand NonsterileZ-2221-2014Zimmer, Inc.
August 20, 2014VER2 HANDLE, PIN REWORK, LT NonsterileZ-2228-2014Zimmer, Inc.
August 20, 2014Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Sy…Z-2180-2014Siemens Medical Solutions USA, Inc
August 20, 2014Sargento Light Ricotta Natural Cheese packaged in 15 ounce plastic tubs.F-2323-2014Miceli Dairy Products Co
August 20, 2014Double Offset Rasp Handle, Left Hand NonsterileZ-2218-2014Zimmer, Inc.
August 20, 2014VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITR…Z-2183-2014ORTHO-CLINICAL DIAGNOSTICS
August 20, 2014Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distrib…D-1535-2014Sung Soo Kim
August 20, 2014E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by …D-1536-2014Bracco Diagnostic Inc
August 20, 2014Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced C…Z-2174-2014Siemens Medical Solutions USA, Inc
August 20, 2014Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyal…Z-2135-2014Enhancement Medical, LLC
August 20, 2014Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-sta…F-2306-2014EBRO North America dba New World Pasta
August 20, 2014VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Produ…Z-2214-2014Ortho-Clinical Diagnostics
August 20, 2014Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured…D-1538-2014Teva Pharmaceuticals USA
August 20, 2014Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism…D-1534-2014Bacai Inc. Dba Ky Duyen House
August 20, 201423.5 Deg Rasp Handle Assy- LEFT NonsterileZ-2230-2014Zimmer, Inc.
August 20, 2014Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pou…Z-2204-2014Gambro Renal Products, Incorporated
August 20, 2014VER2 D8L OFFSET RASP HANDLE, RT NonsterileZ-2225-2014Zimmer, Inc.
August 20, 2014Double Offset Rasp Handle, Left Hand NonsterileZ-2217-2014Zimmer, Inc.
August 20, 2014Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plast…Z-2200-2014Gambro Renal Products, Incorporated
August 20, 2014VER2 HANDLE, PIN REWORK, RT NonsterileZ-2229-2014Zimmer, Inc.
August 20, 2014X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541Z-2207-2014Gambro Renal Products, Incorporated
August 20, 2014Vl DBL OFFST WI LRG STPL, RT NonsterileZ-2223-2014Zimmer, Inc.
August 20, 2014Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # …Z-2208-2014Medical Positioning Inc
August 20, 2014Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 ind…F-2314-2014Interbake Foods Llc
August 20, 2014Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in…Z-2176-2014AGFA Healthcare Corp.
August 20, 2014GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Mode…Z-2120-2014Nidek Inc
August 20, 2014Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's M…F-2313-2014Farmers Market
August 20, 2014Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch,…Z-2193-2014Gambro Renal Products, Incorporated
August 20, 2014CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, …Z-2155-2014Cardiovascular Systems, Inc.
August 20, 2014Fitness Labs Fitness Multi 2, 90 capsules (UPC 654186946203) and 180 capsules (UPC 654186…F-2317-2014Nutrition Express Corporation
August 20, 2014Frederick Farms 4oz chocolate ice cream cups, net wt. 67grams, 24 per box, 231 boxes per …F-2311-2014Garber Ice Cream Company Inc
August 20, 2014Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pou…Z-2205-2014Gambro Renal Products, Incorporated
August 20, 2014Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 p…Z-2197-2014Gambro Renal Products, Incorporated
August 20, 2014PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment …Z-2206-2014Gambro Renal Products, Incorporated
August 20, 2014Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 654186…F-2316-2014Nutrition Express Corporation
August 20, 2014EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 4…Z-2171-2014Intuitive Surgical, Inc.

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