FDA recalls, December 2014: 925 published

168 different companies appear this month.

Risk classification: Class I: 297 · Class II: 603 · Class III: 25

Same month, other agencies:FSIS 13 recallsNHTSA 68 recalls

Recalls this month

DateProduct
December 31, 2014Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahme…D-0325-2015Zydus Pharmaceuticals USA Inc
December 31, 2014Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per b…Z-0872-2015Invacare Corporation
December 31, 2014ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips…Z-0583-2015Heart Sync, Inc.
December 31, 2014HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Ch…D-0324-2015Hospira Inc.
December 31, 2014Centricity Enterprise Archive is a software product for receiving, archiving and sending …Z-0833-2015Ge Healthcare It
December 31, 2014KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimber…Z-0868-2015Halyard Health
December 31, 2014Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2…Z-0864-2015Bausch & Lomb Inc
December 31, 2014Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharmacy Creation…D-0306-2015Pharmacy Creations
December 31, 2014UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for …Z-0855-2015Unistrip Technologies LLC
December 31, 2014Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Nu…Z-0839-2015Instradent USA, Inc.
December 31, 2014Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0…Z-0849-2015Illumina Inc
December 31, 2014HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed fo…Z-0873-2015Radiometer America Inc
December 31, 2014Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Mo…Z-0856-2015Horiba Instruments Inc
December 31, 2014sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Ac…D-0318-2015J. Strickland and Co
December 31, 2014Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharm…D-0307-2015Pharmacy Creations
December 31, 2014KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimber…Z-0869-2015Halyard Health
December 31, 2014New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged i…D-0315-2015New Life Nutritional Center
December 31, 2014Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottle…D-0321-2015K C Pharmaceuticals Inc
December 31, 2014Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System…Z-0838-2015Siemens Healthcare Diagnostics, Inc.
December 31, 2014NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Fe…Z-0851-2015Zimmer Trabecular Metal Technology, Inc.
December 31, 2014Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen &…D-0319-2015LNK International, Inc.
December 31, 2014Whole Foods Tarte Aux Pomme 10 inch, packaged in a brown box. Net Wt. 2 lb 8 oz. UPC: …F-0750-2015Whole Food Market
December 31, 2014Coca Cola Zero, 2 liter pet bottle, UPC 49000 05014, The Coca Cola CompanyF-0754-2015Coca-Cola Company (The)
December 31, 2014MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-…D-0314-2015Chaotic Labz
December 31, 2014DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP…Z-0837-2015Mindray DS USA, Inc. dba Mindray North America
December 31, 2014UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is …Z-0861-2015US Endoscopy Group Inc
December 31, 2014Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach …Z-0853-2015Zimmer, Inc.
December 31, 2014Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetr…D-0323-2015K C Pharmaceuticals Inc
December 24, 2014PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 Laparoscopic Manual Instrument…Z-0735-2015Stryker Endoscopy
December 24, 2014PKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351. Laparoscopic Manual Instruments are …Z-0693-2015Stryker Endoscopy
December 24, 2014PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic Manual Inst…Z-0617-2015Stryker Endoscopy
December 24, 2014PKG, RING HANDLE, P/N 0250080236. Laparoscopic Manual Instruments are intended for cutt…Z-0626-2015Stryker Endoscopy
December 24, 2014PKG, BABCOCK FORCEPS, P/N 0250080241. Laparoscopic Manual Instruments are intended for …Z-0629-2015Stryker Endoscopy
December 24, 2014PKG, FUNDUS FORCEPS, P/N 0250080315. Laparoscopic Manual Instruments are intended for cu…Z-0678-2015Stryker Endoscopy
December 24, 2014VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Softw…Z-0821-2015MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
December 24, 2014Concha Pink- pastry containing soy, eggs, wheat and FD&C Yellow #5 and #6, and Red #3 and…F-0734-2015Mexicantown Bakery, Inc
December 24, 2014Orejas- pastry containing soy, eggs, wheat and milkF-0730-2015Mexicantown Bakery, Inc
December 24, 2014PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM, P/N 0250080590 Laparoscopic Manual In…Z-0715-2015Stryker Endoscopy
December 24, 2014PKG, BABCOCK FORCEPS, P/N 0250080321. Laparoscopic Manual Instruments are intended for c…Z-0684-2015Stryker Endoscopy
December 24, 2014PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are in…Z-0653-2015Stryker Endoscopy
December 24, 2014AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subf…Z-0805-2015American Medical Systems, Inc.
December 24, 2014PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 Laparoscopic Manual Inst…Z-0785-2015Stryker Endoscopy
December 24, 2014Concha Blancas- pastry containing soy, eggs, wheat and FD&C Yellow #5 and #6.F-0731-2015Mexicantown Bakery, Inc
December 24, 2014PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Ins…Z-0622-2015Stryker Endoscopy
December 24, 2014PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manual Instrumen…Z-0780-2015Stryker Endoscopy
December 24, 2014Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems a…Z-0809-2015Siemens Medical Solutions USA Inc.
December 24, 2014PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are …Z-0601-2015Stryker Endoscopy
December 24, 2014Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitorin…Z-0831-2015Integra LifeSciences Corp.
December 24, 2014PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments ar…Z-0778-2015Stryker Endoscopy
December 24, 2014PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 Laparoscopic Manual Instruments …Z-0593-2015Stryker Endoscopy

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