FDA recalls, September 2013: 423 published

152 different companies appear this month.

Risk classification: Class I: 43 · Class II: 358 · Class III: 22

Same month, other agencies:CPSC 19 recallsNHTSA 50 recalls

Recalls this month

DateProduct
September 11, 2013LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-solu…Z-2154-2013Genzyme Corporation, A Sanofi Company
September 11, 2013Baltic Sprats in Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip Interna…F-1865-2013Zip International Group LLC.
September 11, 2013Chocolate covered raisinsin 4 oz flexible bags labeled in part "***Pennsylvania Dutch Can…F-1864-2013The Warrell Corporation
September 11, 2013CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., …D-928-2013Teva Pharmaceuticals USA, Inc.
September 11, 2013LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS…Z-2140-2013Genzyme Corporation, A Sanofi Company
September 11, 2013LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-sol…Z-2156-2013Genzyme Corporation, A Sanofi Company
September 11, 2013Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)F-1875-2013Justin'S Nut Butter
September 11, 2013DMLC IV-ERGO - Beam shaping block for Radiation Therapy.Z-2157-2013Elekta, Inc.
September 11, 2013Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific I…F-1873-2013Crown Pacific Int'L Llc
September 11, 2013CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spin…Z-2132-2013DePuy Spine, Inc.
September 11, 2013Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)F-1874-2013Justin'S Nut Butter
September 11, 2013LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS…Z-2141-2013Genzyme Corporation, A Sanofi Company
September 11, 2013LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, …Z-2152-2013Genzyme Corporation, A Sanofi Company
September 11, 2013Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz…F-1866-2013Conagra Inc
September 11, 2013THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.…F-1867-2013Thrive Foods LLC
September 11, 2013LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 …Z-2143-2013Genzyme Corporation, A Sanofi Company
September 11, 2013Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile …Z-2159-2013MicroAire Surgical Instruments, LLC
September 11, 2013LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-solu…Z-2148-2013Genzyme Corporation, A Sanofi Company
September 11, 2013LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: L…Z-2145-2013Genzyme Corporation, A Sanofi Company
September 11, 2013ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: AD…Z-2135-2013Siemens Healthcare Diagnostics
September 11, 2013Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 S…F-1863-2013Tortilleria Lupita, Inc.
September 11, 2013LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 …Z-2142-2013Genzyme Corporation, A Sanofi Company
September 11, 2013Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.…Z-2138-2013Boston Scientific Corporation
September 11, 2013CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDEN…Z-2133-2013DePuy Spine, Inc.
September 11, 2013Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Food…F-1868-2013Potters Fine Foods, LLC
September 4, 2013Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 600…D-926-2013Hospira, Inc.
September 4, 2013Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, Ne…D-921-2013Bethel Nutritional Consulting, Inc
September 4, 2013ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugb…D-919-2013Advance Pharmaceutical Inc
September 4, 2013Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) re…Z-2130-2013Stryker Howmedica Osteonics Corp.
September 4, 2013DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx On…Z-2113-2013DeRoyal Industries Inc
September 4, 2013ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood gl…Z-2109-2013Roche Diagnostics Operations, Inc.
September 4, 2013TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem d…Z-2073-2013Waldemar Link GmbH & Co. KG (Corp. Hq.)
September 4, 2013PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 …Z-2095-2013Siemens Medical Solutions USA, Inc
September 4, 2013Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT…Z-2118-2013Ventana Medical Systems Inc
September 4, 2013"***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, …F-1855.2013Quesos Vaca Negra, Inc.
September 4, 2013SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY …Z-2052-2013Sarken, Inc.
September 4, 2013NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-E…Z-2046-2013Nidek Inc
September 4, 2013SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (E…Z-2049-2013Sarken, Inc.
September 4, 2013PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1…Z-2047-2013Siemens Healthcare Diagnostics
September 4, 2013TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem …Z-2062-2013Waldemar Link GmbH & Co. KG (Corp. Hq.)
September 4, 2013TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem d…Z-2072-2013Waldemar Link GmbH & Co. KG (Corp. Hq.)
September 4, 2013TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem …Z-2074-2013Waldemar Link GmbH & Co. KG (Corp. Hq.)
September 4, 2013Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R…Z-2104-2013Medtronic Inc. Cardiac Rhythm Disease Management
September 4, 2013Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for t…Z-2045-2013Micro Therapeutics Inc, Dba Ev3 Neurovascular
September 4, 2013Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9F-1852-2013Buurma Farms Inc
September 4, 20132008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional acce…Z-2082-2013Fresenius Medical Care Holdings, Inc. dba Renal Solutions
September 4, 2013SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (E…Z-2048-2013Sarken, Inc.
September 4, 2013Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Ca…Z-2099-2013Stryker Howmedica Osteonics Corp.
September 4, 2013Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.Z-2108-2013Siemens Medical Solutions USA, Inc
September 4, 2013TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem …Z-2061-2013Waldemar Link GmbH & Co. KG (Corp. Hq.)

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