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High RiskFDA
Jenis Splendid Ice Creams Llc
Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Produce·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Spiced Pecan Praline- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Violet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Cucumber Granita- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Backyard Mint Straciatella- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Cranberry Royale- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Produce·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Root Beer- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Jenis Splendid Ice Creams Llc
Dark Cocoa Smoked Almond- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
Frozen Food·0 affected·Jul 7, 2008
High RiskFDA
Regulatory Insight, Inc
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiolo...
Diagnostic Devices·43 affected·Jul 1, 2008
High RiskFDA
Ventana Medical Systems Inc
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usag...
Diagnostic Devices·1,217 affected·Jun 12, 2008
High RiskFDA
Servatii Inc
Banana Nut Bread packed in carton, placed in polypropelin Bag 1 lb each
Bakery & Grains·90 affected·Jun 9, 2008
High RiskFDA
Sonora Mills Foods
popchips¿ Sea Salt & Vinegar, Potato Popped Chip Snack, 0.4 oz (UPC 0 82666 76550 9), 0.8 oz (UPC 0 82666 75500 5), 3 oz (UPC 0 82666 70...
Snacks & Candy·17,586 affected·Jun 7, 2008
High RiskFDA
Sonora Mills Foods
Cheddar Mini Rice Snacks under the following brand names: Fred Meyer, 3 oz, UPC 0 11110 90004 3; Kroger, 3 oz, UPC 0 11110 35789 2; Ra...
Snacks & Candy·2,395 affected·Jun 7, 2008
High RiskFDA
Sonora Mills Foods
popchips¿ Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC 0 82666 78800 3
Snacks & Candy·567 affected·Jun 7, 2008
High RiskFDA
Orthosoft, Inc. Dba Zimmer Cas
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software bas...
Medical Devices·10 affected·Jun 4, 2008
High RiskFDA
Toshiba American Medical Systems Inc
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, ...
Respiratory Devices·54 affected·May 13, 2008
High RiskFDA
Beevers Manufacturing & Supply, Inc.
Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film wit...
Respiratory Devices·16,575 affected·May 13, 2008
High RiskFDA
Spinefrontier, Inc.
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc...
Medical Implants·10 affected·May 10, 2008
High RiskFDA
Sagatech Electronics, Inc.
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a s...
Cardiac Devices·152 affected·May 8, 2008
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and ...
Diagnostic Devices·264 affected·May 1, 2008
High RiskFDA
Dako North America Inc.
PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time co...
Medical Devices·136 affected·May 1, 2008
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received...
Medical Devices·757 affected·Feb 27, 2008
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imag...
Cardiac Devices·11,100 affected·Nov 19, 2007
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open o...
Surgical Devices·726 affected·Nov 19, 2007
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional p...
Cardiac Devices·1,349 affected·Nov 19, 2007
High RiskFDA
Ge Oec Medical Systems, Inc
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human a...
Medical Devices·175 affected·Oct 19, 2007
High RiskFDA
Apotex Corp.
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apo...
Oral Drugs·3,063 affected·Jun 14, 2007
High RiskFDA
Apotex Corp.
Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ont...
Oral Drugs·31 affected·Jun 14, 2007
High RiskFDA
Ge Oec Medical Systems, Inc
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician ...
Surgical Devices·82 affected·Mar 27, 2007
High RiskFDA
Ge Oec Medical Systems, Inc
UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnost...
Surgical Devices·82 affected·Mar 27, 2007
High RiskFDA
Beevers Manufacturing & Supply, Inc.
Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i...
Medical Devices·393 affected·Jan 18, 2007
High RiskFDA
Biomet, Inc.
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer ...
Medical Implants·1,050 affected·Dec 12, 2006
High RiskFDA
Ge Oec Medical Systems, Inc
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, sur...
Surgical Devices·717 affected·Nov 20, 2006
High RiskFDA
Ge Oec Medical Systems, Inc
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory use...
Medical Devices·15 affected·Nov 8, 2006
High RiskFDA
Ge Oec Medical Systems, Inc
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneo...
Surgical Devices·99 affected·Oct 11, 2006
High RiskFDA
General Electric Med Systems Llc
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revo...
Diagnostic Devices·3,796 affected·May 31, 2006
High RiskFDA
General Electric Med Systems Llc
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 513...
Medical Devices·3,796 affected·May 31, 2006
High RiskFDA
General Electric Med Systems Llc
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use ...
Diagnostic Devices·3,796 affected·May 31, 2006
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provi...
Medical Devices·364 affected·Dec 27, 2005
High RiskFDA
Jk Products & Services, Inc
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
Medical Devices·1,948 affected·Jul 8, 2005
High RiskFDA
Siemens Hearing Instruments, Inc
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Medical Devices·738 affected·Jul 1, 2005
High RiskFDA
Unilever United States, Inc.
Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic an...
Food·16,500 affected·Dec 7, 212