FDA recalls, November 2013: 499 published

164 different companies appear this month.

Risk classification: Class I: 39 · Class II: 453 · Class III: 7

Same month, other agencies:CPSC 21 recallsNHTSA 99 recalls

Recalls this month

DateProduct
November 13, 2013Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71AF-0092-2014American Laboratories Inc
November 13, 2013KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (…F-0121-2014Kashmir Crown Baking LLC
November 13, 2013HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerl…Z-0170-2014Hamilton Medical, Inc.
November 13, 2013Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 5 LB (2.26kg) Paper…F-0111-2014J M Smucker Co
November 13, 2013Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45AF-0091-2014American Laboratories Inc
November 13, 2013Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versio…Z-0016-2014Siemens Medical Solutions USA, Inc
November 13, 2013DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and…Z-0132-2014Carestream Health Inc.
November 13, 2013Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with…Z-0151-2014Ethicon Endo-Surgery Inc
November 13, 2013Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive…Z-0139-2014Intuitive Surgical, Inc.
November 13, 2013Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bot…D-66403-006Mylan Pharmaceuticals Inc.
November 13, 2013Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet c…Z-0167-2014Invacare Corporation
November 13, 2013Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per…D-66447-002West-Ward Pharmaceutical Corp.
November 13, 2013Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdomi…Z-0177-2014Pinook-Usa
November 13, 2013VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3…Z-0169-2014Vital Images, Inc.
November 13, 2013Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton…D-66318-001Amgen, Inc.
November 13, 2013Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler …Z-0148-2014Fresenius Medical Care Holdings, Inc.
November 13, 2013Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia fami…Z-0157-2014Smiths Medical ASD, Inc.
November 13, 2013Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc.…D-66403-011Mylan Pharmaceuticals Inc.
November 13, 2013ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyze…Z-0152-2014Beckman Coulter Inc.
November 13, 2013S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert…Z-0142-2014Sorin Group Deutschland GmbH
November 13, 2013Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only…D-66403-002Mylan Pharmaceuticals Inc.
November 13, 2013Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Pr…Z-0085-2014Baylis Medical Corp *
November 13, 2013COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001,…Z-0168-2014Roche Diagnostics Operations, Inc.
November 6, 2013MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for:…Z-0082-2014Maquet Medical Systems USA
November 6, 2013Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are in…Z-0102-2014Siemens Healthcare Diagnostics Inc
November 6, 2013the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Dis…F-0083-2014Barrel O' Fun Snack Foods Co.
November 6, 2013PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and …Z-0094-2014DePuy Spine, Inc.
November 6, 2013Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.Z-0126-2014Carestream Health, Inc.
November 6, 2013Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imagingZ-0119-2014Toshiba American Medical Systems Inc
November 6, 2013HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden Th…Z-0086-2014HemoCue AB
November 6, 2013Synthes Application Instrument Sternal Zip Flex System intended for use in primary or …Z-0114-2014Synthes USA HQ, Inc.
November 6, 2013Xoran MiniCAT00202Z-0040-2014Xoran Technologies, Inc.
November 6, 2013Xoran Mini CT ScannerZ-0036-2014Xoran Technologies, Inc.
November 6, 2013P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 3…F-0085-2014Conagra Inc
November 6, 2013Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that c…Z-0067-2014Philips Medical Systems (Cleveland) Inc
November 6, 2013Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 P…F-0086-2014Schwebel Baking Company
November 6, 2013Sidus" Head (Not distributed in the United States)Z-0079-2014Zimmer, Inc.
November 6, 2013Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affili…Z-0109-2014Baxter Healthcare Corp.
November 6, 2013Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submuco…Z-0112-2014Fujinon Inc
November 6, 2013PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and H…Z-0095-2014DePuy Spine, Inc.
November 6, 2013PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endos…Z-0084-2014Pentax Medical Company
November 6, 2013Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon…D-66200-001Fallon Wellness Pharmacy Llc
November 6, 2013CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM …Z-0069-2014Zimmer, Inc.
November 6, 2013Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Syste…Z-0105-2014Siemens Healthcare Diagnostics Inc
November 6, 2013Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 Syste…Z-0104-2014Siemens Healthcare Diagnostics Inc
November 6, 2013Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Sys…Z-0106-2014Siemens Healthcare Diagnostics Inc
November 6, 2013Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives m…Z-0118-2014Ge Healthcare It
November 6, 2013Natural-Knee¿ II Femoral ComponentZ-0078-2014Zimmer, Inc.
November 6, 2013Xoran Minicat00202Z-0038-2014Xoran Technologies, Inc.
November 6, 2013Xoran MiniCAT CT Scanner ID ENT00001Z-0041-2014Xoran Technologies, Inc.

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