FDA recalls, April 2013: 314 published

143 different companies appear this month.

Risk classification: Class I: 37 · Class II: 230 · Class III: 47

Same month, other agencies:CPSC 25 recallsNHTSA 59 recalls

Recalls this month

DateProduct
April 17, 2013IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Fac…Z-1070-2013AGFA Corp.
April 17, 2013GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dua…Z-1078-2013GE Healthcare, LLC
April 17, 2013Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tab…D-245-2013Teva Pharmaceuticals USA, Inc.
April 17, 2013LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.Z-1089-2013Lighthouse For The Blind
April 17, 2013Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Who…Z-1068-2013Toshiba American Medical Systems Inc
April 17, 2013Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 ozF-1309-2013Red Eagle Enterprises
April 17, 2013GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce o…F-1302-2013Domega NY International Co Ltd
April 17, 2013ShanTea Ride The Dragon Honeybush/Licorice (UPC 794504283808) USDA Organic.F1306-2013ShanTea LLC
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1043-2013Siemens Medical Solutions USA, Inc
April 10, 2013Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Syst…Z-1032-2013Beckman Coulter Inc.
April 10, 2013Mrs. Bridges Scottish Raspberry Preserve ("Jam"); Net Wt. 42g /1.5oz; service size 15g; …F-1284-2013The TJX Companies, Inc.
April 10, 2013Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay…Z-1034-2013Beckman Coulter Inc.
April 10, 2013Brunswick and Bumble Bee Brand 5oz Chunk Light Tuna in Water.F-1288-2013Bumble Bee International
April 10, 2013TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Di…D-240-2013Ferring Pharmaceuticals Inc
April 10, 2013Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 052327…Z-1028-2013Roche Diagnostics Operations, Inc.
April 10, 2013STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Steril…Z-1026-2013Advanced Sterilization Products
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1040-2013Siemens Medical Solutions USA, Inc
April 10, 2013Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the t…Z-1031-2013Medtronic Neuromodulation
April 10, 2013Tender Twist 100% Whole Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRI…F-1282-2013Kroger Co
April 10, 2013Fred Meyer Tender Twist Honey Cracked Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: U…F-1283-2013Kroger Co
April 10, 20130.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, I…D-243-2013Hospira Inc.
April 10, 2013America Farm Peanut Granules, bulk packed in 30 lb plastic bags in a box, and labeled in …F-1294-2013Producers Peanut Company Inc
April 10, 2013Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intra…Z-1030-2013Integra Burlington MA, Inc.
April 10, 2013CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. …F-2177-2013Chu Minh Corp
April 10, 2013Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomogra…Z-1029-2013Philips Medical Systems (Cleveland) Inc
April 10, 2013Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake, 14 oz, in a plastic clamshe…F-1285-2013Gold Standard Baking, Inc.
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1042-2013Siemens Medical Solutions USA, Inc
April 10, 2013Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC …D-239-2013Dr Reddys Laboratories Tennessee LLC
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1044-2013Siemens Medical Solutions USA, Inc
April 10, 2013Chicken of the Sea Brand 5-ounce chunk white albacore tuna in water. UPC: 4800003355, Ca…F-1274-2013Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
April 10, 2013Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood…Z-1024-2013Zyno Medical LLC
April 10, 2013Bumble Bee Brand 5oz Chunk Light Tuna in Vegetable OilF-1289-2013Bumble Bee International
April 10, 2013Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 c…D-233-2013Palmer Natural Products
April 10, 2013Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measu…Z-1048-2013Siemens Healthcare Diagnostics, Inc.
April 10, 2013Happy Kids Crunchy Peanut butter, packed in 8 oz, 12 oz, 28 oz, packed 12 jars/cs and 40 …F-1292-2013Producers Peanut Company Inc
April 10, 2013Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus…Z-1049-2013Siemens Healthcare Diagnostics, Inc.
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1041-2013Siemens Medical Solutions USA, Inc
April 10, 2013Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapi…Z-1059-2013Polymedco, Inc
April 10, 2013Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).…Z-1055-2013LeMaitre Vascular, Inc.
April 10, 2013ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consi…Z-1050-2013Horiba Instruments, Inc dba Horiba Medical
April 10, 2013Propolis Powder -100% Standardized Bee-Propolis Lot #: 021113-55/60, EXP: 10/14 11# Bag &…F-1286-2013Beehive Botanicals, Inc.
April 10, 2013Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark pap…Z-1025-2013Viscot Medical LLC
April 10, 2013Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measur…Z-1046-2013Siemens Healthcare Diagnostics, Inc.
April 10, 2013LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thi…Z-1053-2013Cooper Surgical, Inc.
April 10, 2013STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilizat…Z-1027-2013Advanced Sterilization Products
April 10, 2013BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostY…D-235-2013Palmer Natural Products
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1037-2013Siemens Medical Solutions USA, Inc
April 10, 2013Propolis Chunks-Coarse Ground, Standardized Bee Propolis Lot #: SDM-10081155/60, EXP: 10/…F-1287-2013Beehive Botanicals, Inc.
April 10, 2013CHU MINH TOFU Fried Soybean Cake (Tofu), net weight 12 oz. The UPC is 8 18140 00003 9. …F-2178-2013Chu Minh Corp
April 10, 2013SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; …Z-1036-2013Siemens Medical Solutions USA, Inc

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