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, 2014Philips IP5 Information Portal The Expression Information Portal (Model IP5), a displa…Z-2270-2014Invivo Corporation
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2282-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2284-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom …Z-2300-2014Zimmer, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2272-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORA…Z-2242-2014Biomet, Inc.
August 27, 2014Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle …D-1541-2014Wockhardt Usa Inc.
August 27, 2014Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes…Z-2295-2014ICU Medical, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2280-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile …Z-2288-2014Zimmer, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2285-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No…Z-2263-2014Biolase Technology Inc
August 27, 2014Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmerZ-2244-2014Zimmer, Inc.
August 27, 2014Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top …Z-2301-2014Zimmer, Inc.
August 27, 2014XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; Mild; NET WT. 11.5 OZ (32…F-2341-2014Renfro Foods, Inc.
August 27, 2014Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmerZ-2245-2014Zimmer, Inc.
August 27, 2014Product is in a 160 gram, light green tin container, labeled in part: "ecoato Sweet Papri…F-2333-2014The TJX Companies, Inc.
August 27, 2014Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to…Z-2254-2014Ortho Development Corporation
August 27, 2014Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use On…Z-2259-2014Medtronic Neuromodulation
August 27, 20140.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Health…D-1550-2014Baxter Healthcare Corp.
August 27, 2014Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom …Z-2297-2014Zimmer, Inc.
August 27, 2014Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top …Z-2299-2014Zimmer, Inc.
August 27, 20144.0 mm Cancellous Screw, Partially Threaded Sterile ZimmerZ-2251-2014Zimmer, Inc.
August 27, 2014Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HAZ-2241-2014Omnilife Science Inc.
August 27, 2014DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Man…D-1540-2014Hospira Inc.
August 27, 2014Philips IntelliSpace ECG Management System, with software option C61 needed to import EC…Z-2535-2014Philips Medical Systems, Inc.
August 27, 20144.5 mm Malleolar Screw Sterile zimmerZ-2250-2014Zimmer, Inc.
August 27, 2014TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software v…Z-2240-2014TomoTherapy Incorporated
August 27, 2014PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding ValveZ-2290-2014Pentax Medical Company
August 27, 2014CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distrib…D-1543-2014Ben Venue Laboratories Inc
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2275-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Philips IntelliSpace PACS 4.4 image management systems performs digital image processing,…Z-2252-2014Philips Healthcare Informatics, Inc.
August 27, 2014CaCoCo Superfood Drinking Chocolate; Global Warrior - Flavor Melody: Dark, Bitter-sweet,…F-2337-2014CaCoCo, Inc.
August 27, 2014Ciranda Organic Carob Powder Light, Product Code 20030. Net Wt. 55.11 lbs / 25 kg. Ing…F-2334-2014Ciranda, Inc.
August 27, 2014Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.…Z-2268-2014Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
August 27, 2014All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, incl…Z-2264-2014Hyperion Medical
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2279-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A WHOLE MILK Pasteurized and Homog…F-2348-2014Fish Family Farm
August 27, 2014Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creat…D-1546-2014Pharmacy Creations
August 27, 2014Natural Grocers Organic Chunks of Energy Date Flax Turmeric, 0.70 lb. random weight, Pack…F-2336-2014Natural Grocers by Vitamin Cottage
August 27, 2014Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx On…D-1547-2014Hospira Inc.
August 27, 2014Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to suppo…Z-2192-2014Childrens Medical Ventures
August 27, 20146.5 mm Cancellous Screw Fully Threaded Sterile zimmerZ-2246-2014Zimmer, Inc.
August 27, 2014IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device t…Z-2267-2014Intelerad Medical Systems
August 27, 2014Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog N…Z-2262-2014Angiodynamics, Inc.
August 27, 2014TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith &…Z-2258-2014Smith & Nephew, Inc.
August 27, 20146.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmerZ-2248-2014Zimmer, Inc.
August 27, 2014AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for prim…Z-2276-2014AMO Puerto Rico Manufacturing, Inc.
August 27, 2014Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes …Z-2294-2014ICU Medical, Inc.
August 27, 20146.5 mm Cancellous Screw Fully Threaded Sterile zimmerZ-2249-2014Zimmer, Inc.

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