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 25, 2013Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Us…Z-2207-2013Biomet 3i, LLC
September 25, 2013Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (…Z-2197-2013Assuramed
September 25, 2013Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183D-1050-2013Medaus, Inc.
September 25, 2013Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used…Z-2188-2013B Braun Medical, Inc.
September 25, 2013TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part …Z-2233-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a pro…Z-2201-2013GE Healthcare, LLC
September 25, 2013Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable…F-1903-2013Novartis Consumer Health
September 25, 2013OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 7…Z-2225-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number…Z-2231-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are containe…Z-2199-2013Tornier, Inc
September 25, 2013NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183D-1054-2013Medaus, Inc.
September 25, 2013Bean & Cheese Burrito Filling, 10 lb bags Labeled in part "13210 B 1 77220 13:38 KEEP FRO…F-1902-2013JTM Provisions Co Inc
September 25, 2013GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter…Z-2256-2013GE Healthcare, LLC
September 25, 2013ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pou…Z-2198-2013Assuramed
September 25, 2013King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (i…Z-2255-2013King Systems Corp.
September 25, 2013Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains:…Z-2252-2013Churchill Medical Systems, Inc.
September 25, 2013IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Di…D-1042-2013Dr. Reddy's Laboratories, Inc.
September 25, 2013Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign label…F-1907-2013Novartis Consumer Health
September 25, 2013BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable su…Z-2219-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer desig…Z-2244-2013Instrumentation Laboratory Co.
September 25, 2013Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle…D-1061-2013Watson Laboratories Inc
September 25, 2013GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.Z-2241-2013GE Healthcare, LLC
September 25, 2013L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183D-1051-2013Medaus, Inc.
September 25, 2013Olde Cape Cod Chipotle Ranch dressing, 16 oz. Item Number: 90997-11630F-1892-2013Cains Foods L.P.
September 25, 2013C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous den…Z-2205-2013Camlog Usa
September 25, 2013BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegr…Z-2215-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: …Z-2224-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183D-1053-2013Medaus, Inc.
September 25, 2013Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL…D-1044-2013JCB Labs LLC
September 25, 2013ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed…Z-2246-2013Instrumentation Laboratory Co.
September 25, 2013TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 …Z-2232-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Roa…Z-2209-2013Cincinnati Sub-Zero Products Inc
September 25, 2013DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls fo…Z-2196-2013Assuramed
September 25, 2013TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegrad…Z-2236-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183D-1052-2013Medaus, Inc.
September 25, 2013Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183D-1048-2013Medaus, Inc.
September 25, 2013Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch ex…Z-2251-2013Churchill Medical Systems, Inc.
September 25, 2013Tagine Sauce, 16 fl. oz., 12 jars/caseF-1890-2013Premier Foods, LLC
September 25, 2013OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165…Z-2226-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013Vancomycin PF (BSS) 1%, 1 mL, Avella Specialty Pharmacy, Phoenix, AZ 85085, 877-782-7684D-1059-2013Avella of Deer Valley, Inc.
September 25, 2013NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183D-1055-2013Medaus, Inc.
September 25, 2013C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous den…Z-2204-2013Camlog Usa
September 25, 2013Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Orange; All Natural, 55% …F-1889-2013G. Debbas Chocolatier, Inc.
September 25, 2013Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc. HIF-1883-2013New Dream Team
September 25, 2013Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, …F-1905-2013Novartis Consumer Health
September 25, 2013POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to …Z-2254-2013Access Scientific Inc
September 25, 2013TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 7220260…Z-2234-2013Smith & Nephew, Inc. Endoscopy Division
September 25, 2013Coffee Cake: queso/fresa (cheese/strawberry)F-1900-2013Jean's Cake
September 25, 2013Artichoke Pecorino Sauce, 16 fl. oz., 12 jars/caseF-1891-2013Premier Foods, LLC
September 25, 2013Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compound…D-1039-2013Leiter's Pharmacy

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