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High RiskFDA
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use...
Medical Implants·4 affected·Jan 24, 2013
High RiskFDA
Intuitive Surgical, Inc.
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral S...
Surgical Devices·1,374 affected·Jan 24, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10)...
Oral Drugs·3,913 affected·Jan 23, 2013
High RiskFDA
Bard Peripheral Vascular Inc
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, ...
Medical Implants·315 affected·Jan 23, 2013
High RiskFDA
Bard Peripheral Vascular Inc
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered ti...
Surgical Devices·17 affected·Jan 23, 2013
High RiskFDA
Bard Peripheral Vascular Inc
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; ...
Surgical Devices·223 affected·Jan 23, 2013
High RiskFDA
Annie's Homegrown Inc
Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.....
Dairy·43 affected·Jan 22, 2013
High RiskFDA
Annie's Homegrown Inc
Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package...
Dairy·43 affected·Jan 22, 2013
High RiskFDA
Annie's Homegrown Inc
Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0...
Dairy·43 affected·Jan 22, 2013
High RiskFDA
Rx South Llc Dba Rx3 Pharmacy
Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 ...
Injectable Drugs·126 affected·Jan 22, 2013
High RiskFDA
Fresenius Kabi Usa Llc (fk Usa)
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, S...
Injectable Drugs·23,672 affected·Jan 22, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Sus...
Medical Devices·297 affected·Jan 21, 2013
High RiskFDA
Arjo, Inc. Dba Arjohuntleigh
Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. I...
Medical Devices·363 affected·Jan 21, 2013
High RiskFDA
Pamela's Products, Inc.
Pamela's Chocolate Cake Mix; Gluten Free, Wheat Free, Non Dairy 21 oz. package. UPC 93709-30040 Pamela's Products, Ukiah, CA 95482
Dairy·967 affected·Jan 19, 2013
High RiskFDA
Pamela's Products, Inc.
Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free 24 oz package. UPC 93709-30010 Pamela's Products, Ukiah, CA 95482
Bakery & Grains·2 affected·Jan 19, 2013
High RiskFDA
Pamela's Products, Inc.
Pamela's Chocolate Chunk Cookie Mix; Gluten Free, Wheat Free, Non Dairy 13.9 oz. package. UPC 93709-30050 Pamela's Products, Ukiah, ...
Dairy·1,709 affected·Jan 19, 2013
High RiskFDA
Pamela's Products, Inc.
Pamela's Peanut Butter Chocolate Chip Cookies; Gluten Free 5.29 oz. package. UPC 93709-40180 Pamela's Products, Ukiah, CA 95482
Dairy·523 affected·Jan 19, 2013
High RiskFDA
Elekta, Inc.
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Medical Devices·1 affected·Jan 18, 2013
High RiskFDA
Aesculap, Inc.
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Surgical Devices·59 affected·Jan 18, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business...
Medical Devices·214 affected·Jan 18, 2013
High RiskFDA
Humco Holding Group, Inc
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and inse...
Drugs·1,269,846 affected·Jan 17, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS sys...
Medical Devices·5 affected·Jan 17, 2013
High RiskFDA
Bimbo Bakeries Usa
Sara Lee Deluxe Bagels, 20 oz packages; BLUEBERRY, PLAIN, CINNAMON RAISIN,and HONEY WHEAT varieties.
Produce·57,492 affected·Jan 16, 2013
High RiskFDA
Bimbo Bakeries Usa
Thomas' Bagels, 1 lb 4 oz packages; EVERYTHING, ONION, BLUEBERRY, PLAIN, CINNAMON RAISIN, HEARTY GRAINS 100% WHOLE WHEAT, CINNAMON SWIRL ...
Produce·418,356 affected·Jan 16, 2013
High RiskFDA
Bimbo Bakeries Usa
Weight Watchers 6 Original Bagels, 15 oz packages
Food·4,032 affected·Jan 16, 2013
High RiskFDA
Bimbo Bakeries Usa
Publix Premium Bagels, 20 oz packages; ORIGINAL, MULTI-GRAIN, and CINNAMON RAISIN SWIRL varieties.
Food·34,020 affected·Jan 16, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 037...
Oral Drugs·11,580 affected·Jan 16, 2013
High RiskFDA
Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making...
Diagnostic Devices·116 affected·Jan 16, 2013
High RiskFDA
Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Univ...
Diagnostic Devices·177 affected·Jan 16, 2013
High RiskFDA
Greatbatch Medical
45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164...
Surgical Devices·913 affected·Jan 16, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary...
Surgical Devices·387 affected·Jan 16, 2013
High RiskFDA
Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This s...
Diagnostic Devices·66 affected·Jan 16, 2013
High RiskFDA
Nuera Trading Company Incorporated
Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10...
Food·580 affected·Jan 15, 2013
High RiskFDA
Depuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicate...
Medical Devices·7,773 affected·Jan 15, 2013
High RiskFDA
Depuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fi...
Medical Devices·6,668 affected·Jan 15, 2013
High RiskFDA
Depuy Spine, Inc.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for...
Medical Devices·549 affected·Jan 15, 2013
High RiskFDA
Atricure Inc
Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency...
Cardiac Devices·5 affected·Jan 14, 2013
High RiskFDA
Oxus America, Inc.
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable ...
Respiratory Devices·1,724 affected·Jan 14, 2013
High RiskFDA
Ansell Healthcare Products Llc
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which comp...
Medical Devices·469,134 affected·Jan 14, 2013
High RiskFDA
Breg Inc
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410...
Medical Devices·44,883 affected·Jan 14, 2013
High RiskFDA
Dawn's Foods, Inc.
Dawns Alaskan Krab and Shrimp Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 70103 8 MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901 Ocean...
Seafood·7,470 affected·Jan 11, 2013
High RiskFDA
Dawn's Foods, Inc.
Ocean Harbor Jalapeno Krab Spread Net Wt 5 lbs (2.27kg) UPC: 0 32345-77715 6 Dist by Roundy's Inc.
Food·1,250 affected·Jan 11, 2013
High RiskFDA
Dawn's Foods, Inc.
Ocean Harbor Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1 Dist by Roundy's Inc.
Seafood·6,940 affected·Jan 11, 2013
High RiskFDA
Dawn's Foods, Inc.
Five Star Dip Cajun Krab Dip Net Wt 10 oz (284g). UPC: 0 32345 84063 8, Mfg By Dawns Foods, Inc., Portage, WI 53901. 84080 Dawns ...
Food·4,176 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·5 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·64 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·56 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Den...
Medical Devices·148 affected·Jan 11, 2013