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High RiskFDA
The Anspach Effort, Inc.
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·574 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material...
Medical Devices·68 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, p...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Medical Devices·492 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone materia...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
The Anspach Effort, Inc.
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, ...
Medical Devices·6,439 affected·Mar 29, 2012
High RiskFDA
Advanced Neuromodulation Systems Inc.
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Medical Implants·388 affected·Mar 28, 2012
High RiskFDA
Jugos Naturales Del Pepino, Inc.
Jugos Naturales del Pepino, Jugo de China Natural (Natural Orange Juice), 1 Gal (128 oz), Este producto no est¿ pasteurizado (This produc...
Beverages·29 affected·Mar 27, 2012
High RiskFDA
Maquet Cardiovascular, Llc
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide tempora...
Medical Devices·29 affected·Mar 27, 2012
High RiskFDA
Topcon Medical Laser Systems, Inc
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Medical Devices·7 affected·Mar 27, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Medical Devices·318 affected·Mar 27, 2012
High RiskFDA
Nidek Inc
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like di...
Medical Devices·16 affected·Mar 27, 2012
High RiskFDA
Tango3 Llc
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE,...
Medical Devices·44 affected·Mar 26, 2012
High RiskFDA
Biomet 3i, Llc
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC A...
Medical Implants·240 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft UPC 03500068762 Dist. by Colgate-Palmolive Co. New York, N...
Medical Devices·280,044 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For te...
Medical Devices·6,006 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made ...
Medical Devices·280,044 affected·Mar 23, 2012
High RiskFDA
B. Braun Medical, Inc.
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to s...
Medical Devices·13,078 affected·Mar 23, 2012
High RiskFDA
Colgate Palmolive Company
Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made...
Medical Devices·280,044 affected·Mar 23, 2012
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) pack...
Topical Drugs·185,160 affected·Mar 22, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Diagnostic Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain Syringing Pipettes 240 (Catalog #490517)
Medical Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Tripath Imaging, Inc.
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syr...
Medical Devices·46,112,784 affected·Mar 22, 2012
High RiskFDA
Evergreen Orchard Farm, Llc
Korean Pear Juice in 120 mL metal foil pouch single service container. Made by Evergreen Orchard Farm, 1023 Yardville Allentown Road, Ha...
Beverages·0 affected·Mar 16, 2012
High RiskFDA
Evergreen Orchard Farm, Llc
Evergreen Farm Pear Juice Gochujang (Hot Peppeer Paste). Net Wt 70 ounce (4.4 LBS) glass jars. 1023 Yardville Allentown Road, Hamilton ...
Beverages·0 affected·Mar 16, 2012
High RiskFDA
Evergreen Orchard Farm, Llc
Evergreen Farm Doen Jang (Soybean Paste). Net Wt, 70 ounces (4.4 LBS) in glass jars. 1023 Yardville Allentown Road, Hamilton NJ 08620. ...
Food·0 affected·Mar 16, 2012
High RiskFDA
Evergreen Orchard Farm, Llc
Korean Grape Juice, 110 mL metal foil pouch single service container. Made by Evergreen Orchard Farm, 1023 Yardville Allentown Road, Ham...
Beverages·0 affected·Mar 16, 2012
High RiskFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is ...
Medical Devices·126 affected·Mar 15, 2012
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad...
Oral Drugs·1,176 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Huma...
Medical Devices·208 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Hu...
Medical Devices·160 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tis...
Medical Devices·25 affected·Mar 14, 2012
High RiskFDA
Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Medical Devices·2,457 affected·Mar 13, 2012
High RiskFDA
Medtest Holdings, Inc.
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is ...
Diagnostic Devices·270 affected·Mar 13, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electro...
Medical Devices·376 affected·Mar 12, 2012
High RiskFDA
Aurobindo Pharma Ltd
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma L...
Oral Drugs·23,616 affected·Mar 9, 2012
High RiskFDA
Princeton Biomeditech Corp
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-7...
Respiratory Devices·103 affected·Mar 9, 2012
High RiskFDA
Princeton Biomeditech Corp
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B te...
Respiratory Devices·90 affected·Mar 9, 2012
High RiskFDA
Shionogi Inc.
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufacture...
Oral Drugs·7,230 affected·Mar 8, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination...
Medical Implants·20 affected·Mar 7, 2012
High RiskFDA
Aesculap Implant Systems Llc
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical ...
Medical Devices·15 affected·Mar 7, 2012
High RiskFDA
Abbott Point Of Care Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receivi...
Medical Devices·2,950,296 affected·Mar 1, 2012
High RiskFDA
Lloyd Inc
Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601.
Drugs·1,913,236 affected·Feb 24, 2012
High RiskFDA
Lloyd Inc
Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmace...
Oral Drugs·19,039 affected·Feb 24, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza. Radiological image processing system
Medical Devices·2 affected·Feb 24, 2012
High RiskFDA
American Optisurgical Inc
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tiss...
Surgical Devices·5 affected·Feb 22, 2012
High RiskFDA
Biomet Spine, Llc
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum ...
Medical Devices·213 affected·Feb 22, 2012