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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Raysearch Laboratories Ab
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Medical Devices·251 affected·Feb 14, 2014
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ...
Medical Devices·36 affected·Feb 14, 2014
High RiskFDA
C. H. Guenther & Sons, Inc.
MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)
Bakery & Grains·1,296 affected·Feb 13, 2014
High RiskFDA
Raymond-hadley Corp.
STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHE...
Bakery & Grains·7,476 affected·Feb 13, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patc...
Topical Drugs·117,600 affected·Feb 13, 2014
High RiskFDA
Healix Infusion Therapy, Inc.
BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park...
Drugs·10 affected·Feb 13, 2014
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count pat...
Topical Drugs·187,860 affected·Feb 13, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enab...
Medical Devices·12 affected·Feb 13, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feat...
Cardiac Devices·10,211 affected·Feb 13, 2014
High RiskFDA
Accumetrics Inc
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a...
Diagnostic Devices·576 affected·Feb 13, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-cou...
Oral Drugs·257,904 affected·Feb 12, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, ...
Oral Drugs·72,356 affected·Feb 12, 2014
High RiskFDA
Biosense Webster, Inc.
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC ...
Surgical Devices·8 affected·Feb 12, 2014
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Injectable Drugs·603,768 affected·Feb 11, 2014
High RiskFDA
Synthes, Inc.
The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
Medical Devices·20 affected·Feb 11, 2014
High RiskFDA
Ams Diagnostics, Llc
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Medical Devices·13 affected·Feb 11, 2014
High RiskFDA
Tortillas Mexico Mexico, Incorporated
CORN TORTILLAS: 18 CT YELLOW/WHITE 18 OZ USPC Code 1569603333, 36 COUNT YELLOW/WHITE 36 OZ USPC Code 1569603335/4, 75 COUNT WHITE CORN 5 ...
Food·249,158 affected·Feb 10, 2014
High RiskFDA
Tortillas Mexico Mexico, Incorporated
FLOUR TORTILLAS: FAJITA 6" 15 0Z UPC Code 1569602222, HOMESTYLE 8" 24 OZ UPC Code 1569602221, BURRITO 10" 28OZ UPC Code 1569602223, GRAND...
Food·842,036 affected·Feb 10, 2014
High RiskFDA
Tortillas Mexico Mexico, Incorporated
WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags.
Food·13,954 affected·Feb 10, 2014
High RiskFDA
Hospira Inc.
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 04...
Drugs·115,500 affected·Feb 10, 2014
High RiskFDA
Actavis Elizabeth Llc
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07...
Injectable Drugs·9,447 affected·Feb 10, 2014
High RiskFDA
Thermedx Llc
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid t...
Medical Devices·21 affected·Feb 10, 2014
High RiskFDA
Heraeus Kulzer, Llc.
BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar,...
Medical Devices·812 affected·Feb 10, 2014
High RiskFDA
Biomerieux Inc
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Diagnostic Devices·471 affected·Feb 10, 2014
High RiskFDA
Ohm Laboratories, Inc.
Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15...
Oral Drugs·29,790 affected·Feb 7, 2014
High RiskFDA
Ge Healthcare, Llc
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to ...
Diagnostic Devices·3,062 affected·Feb 7, 2014
High RiskFDA
Djo Surgical
FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shel...
Surgical Devices·10 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a...
Surgical Devices·31,250 affected·Feb 7, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Zee Angiographic x-ray systems.
Medical Devices·9 affected·Feb 7, 2014
High RiskFDA
Pega Medical Inc.
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue...
Medical Implants·5 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter ess...
Surgical Devices·4,760 affected·Feb 7, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic...
Diagnostic Devices·37 affected·Feb 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medici...
Diagnostic Devices·3,062 affected·Feb 7, 2014
High RiskFDA
Biocardia, Inc.
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas,...
Surgical Devices·11 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter ...
Surgical Devices·54,590 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard ca...
Surgical Devices·5,540 affected·Feb 7, 2014
High RiskFDA
Leica Biosystems Imaging, Inc.
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ...
Diagnostic Devices·78 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters Th...
Surgical Devices·600 affected·Feb 7, 2014
High RiskFDA
Mars Food Us
Uncle Ben's (R), Infused(R) Rice Cheese Flavor, net weight 5 LB (2.27 kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, C...
Dairy·0 affected·Feb 6, 2014
High RiskFDA
E. Franco & Co. Inc
"***Brazo gitano (rolled cake)***bavarian cream cake filling***"
Dairy·2,300 affected·Feb 6, 2014
High RiskFDA
Mars Food Us
Uncle Ben's (R), Infused(R) Rice Roasted Chicken Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices...
Meat & Poultry·33,634 affected·Feb 6, 2014
High RiskFDA
E. Franco & Co. Inc
"***Brazo gitano (rolled cake)***chocolate cake filling***"
Bakery & Grains·2,300 affected·Feb 6, 2014
High RiskFDA
Mars Food Us
Uncle Ben's (R), Infused(R) Rice Garlic & Butter Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 5059, R...
Dairy·19,304 affected·Feb 6, 2014
High RiskFDA
E. Franco & Co. Inc
"***Brazo gitano (rolled cake)***strawberry filling***"
Bakery & Grains·2,300 affected·Feb 6, 2014
High RiskFDA
Mars Food Us
Uncle Ben's (R), Infused(R) Rice Mexican Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O...
Food·140,225 affected·Feb 6, 2014
High RiskFDA
E. Franco & Co. Inc
"***Brazo gitano (rolled cake)***guava paste filling***"
Bakery & Grains·2,300 affected·Feb 6, 2014
High RiskFDA
Lyons Magnus
Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz (2kg) UPC 1 00 74865 38258 5 ...
Produce·55 affected·Feb 6, 2014
High RiskFDA
Mars Food Us
Uncle Ben's (R), Infused(R) Rice Saffron Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, C...
Food·43,004 affected·Feb 6, 2014