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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGH...
Medical Devices·591 affected·Nov 14, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours o...
Medical Devices·1,647 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients wit...
Medical Devices·135 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with...
Medical Devices·189 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with...
Medical Devices·189 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro...
Diagnostic Devices·50 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee Sy...
Medical Devices·92 affected·Nov 14, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in v...
Diagnostic Devices·250 affected·Nov 14, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Medical Devices·1 affected·Nov 14, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours o...
Medical Devices·1,647 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee Sy...
Medical Devices·92 affected·Nov 14, 2012
High RiskFDA
Zimmer, Inc.
Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGH...
Medical Devices·429 affected·Nov 14, 2012
High RiskFDA
Cardinal Health
Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC ...
Dairy·1,140 affected·Nov 13, 2012
High RiskFDA
Medtronic Navigation, Inc.
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill ...
Surgical Devices·12 affected·Nov 13, 2012
High RiskFDA
Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath...
Cardiac Devices·10,201 affected·Nov 12, 2012
High RiskFDA
Biomotion Medical Systems, Llc
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch C...
Medical Devices·28 affected·Nov 12, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product ...
Surgical Devices·12 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage:...
Surgical Devices·69 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: ...
Surgical Devices·414 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 ...
Surgical Devices·411 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: ...
Surgical Devices·7 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage:...
Surgical Devices·27 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Produc...
Surgical Devices·35 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 ...
Surgical Devices·155 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: ...
Surgical Devices·5 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage:...
Surgical Devices·17 affected·Nov 10, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 322...
Oral Drugs·120,201 affected·Nov 9, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 322...
Oral Drugs·203,198 affected·Nov 9, 2012
High RiskFDA
Ranbaxy Inc.
Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceutic...
Oral Drugs·157,026 affected·Nov 9, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qual...
Cardiac Devices·588 affected·Nov 9, 2012
High RiskFDA
Spinefrontier, Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric...
Medical Implants·13 affected·Nov 9, 2012
High RiskFDA
Biomet, Inc.
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modula...
Medical Devices·49 affected·Nov 9, 2012
High RiskFDA
Procter & Gamble Co
Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
Drugs·17,532 affected·Nov 8, 2012
High RiskFDA
Moog Medical Devices Group
EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with dispos...
Medical Devices·8,736 affected·Nov 8, 2012
High RiskFDA
Medline Industries Inc
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the...
Medical Devices·105 affected·Nov 8, 2012
High RiskFDA
Ids (immunodiagnostic Systems Ltd.)
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for ...
Diagnostic Devices·675 affected·Nov 7, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
Medical Implants·36 affected·Nov 7, 2012
High RiskFDA
Depuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Medical Implants·6 affected·Nov 7, 2012
High RiskFDA
Quanta System, S.p.a.
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular les...
Surgical Devices·12 affected·Nov 7, 2012
High RiskFDA
Quanta System, S.p.a.
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vasc...
Surgical Devices·22 affected·Nov 7, 2012
High RiskFDA
Cracker Industries, Llc
Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended...
Food·65 affected·Nov 6, 2012
High RiskFDA
Alkermes, Inc.
VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01,...
Injectable Drugs·3,325 affected·Nov 6, 2012
High RiskFDA
Invacare Corporation
Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping ...
Medical Devices·38,280 affected·Nov 6, 2012
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The ...
Medical Devices·12,250 affected·Nov 6, 2012
High RiskFDA
Ethicon Endo-surgery Inc
Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during...
Medical Devices·58,338 affected·Nov 6, 2012
High RiskFDA
Boehringer Ingelheim Roxane Inc
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Rid...
Oral Drugs·8,381 affected·Nov 5, 2012
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191,...
Oral Drugs·2,264 affected·Nov 5, 2012
High RiskFDA
Medrad Inc
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifi...
Cardiac Devices·832,175 affected·Nov 5, 2012