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High RiskFDA
Wako Life Sciences, Inc.
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan ...
Diagnostic Devices·36 affected·Apr 30, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked Salmon (may include any of the following varieties Coho, Keta, King, Sockeye). Jensen's product ...
Seafood·14,628 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked Farmed Raised Salmon (Atlantic, Coho, Keta, King, Steelhead, and Sockeye). AKS (Alaska King Sea...
Seafood·45,436 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Jack's Fish Spot Hot Smoked Cajun Atlantic is a low salt, vacuum packaged, Hot Smoked Salmon. This product is labeled in parts: "***Ho...
Seafood·36,105 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Great Ruby Fish Co products are such as Keta and King Hot smoked salmon. No labels provided. Products are labeled with lot code sticker ...
Seafood·5,125 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked King Nova Salmon. The following is information on the individual products for Alaska King Seafo...
Seafood·3 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked Trout and Arctic Char. Clippership products are labeled in parts: "***IMPORTANT. Keep Frozen. ...
Frozen Food·0 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Hot Smoked Pink Salmon is Low salt, vacuum packaged. Clippership Hot Smoked Pink Salmon does not have any labels. Lummi Island Co-O...
Seafood·20,271 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Hot Smoked Alaskan Sockeye Salmon is a low salt, vacuum packaged. Great Ruby Fish Co Sockeye Hot smoked salmon has no labels. ROLF'...
Seafood·3,446 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked Sturgeon Clippership product is labeled in parts: "***Keep Frozen. Thaw under refrigeration imm...
Frozen Food·0 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked Halibut was sold under brand Clippership. No product labeling was provided.
Food·171 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Short Strips Teriyaki is a low salt, vacuum packaged, Hot Smoked Salmon, and it is sold under Alaska King Seafoods brand. The labels c...
Seafood·5,615 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Savory Hot Smoked Salmon is Farmed Raised product, Low salt, vacuum packaged. Savory Smoked Salmon produced by Jensen's Smokehouse is ...
Seafood·10,971 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Hot Smoked Black Cod sold under Clippership. No label was provided.
Food·0 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks is a low salt, vacuum packaged, hot smoked salmon. The product is labeled ...
Seafood·36,105 affected·Apr 29, 2013
High RiskFDA
Jensens Old Fashioned Smokehouse Inc
Low salt, vacuum packaged, Garlic Pepper Hot Smoked Salmon with Hardwood. AKS (Alaska King Salmon) product is labeled in parts: "***Ga...
Seafood·0 affected·Apr 29, 2013
High RiskFDA
Zip International Group Llc.
Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709
Food·11 affected·Apr 26, 2013
High RiskFDA
Cardio Medical Products
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only M...
Cardiac Devices·657 affected·Apr 26, 2013
High RiskFDA
Heart Sync, Inc
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation ...
Cardiac Devices·17,180 affected·Apr 26, 2013
High RiskFDA
Beckman Coulter Inc.
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body flui...
Medical Devices·108 affected·Apr 26, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgi...
Surgical Devices·13 affected·Apr 26, 2013
High RiskFDA
Biomet, Inc.
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Medical Devices·8 affected·Apr 26, 2013
High RiskFDA
Maple View Ice Cream
Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Dairy·0 affected·Apr 25, 2013
High RiskFDA
Maple View Ice Cream
Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Dairy·0 affected·Apr 25, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure ...
Diagnostic Devices·13,751 affected·Apr 25, 2013
High RiskFDA
The Anspach Effort, Inc.
***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and...
Medical Devices·12 affected·Apr 25, 2013
High RiskFDA
Hologic, Inc.
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provi...
Surgical Devices·287 affected·Apr 25, 2013
High RiskFDA
The Anspach Effort, Inc.
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
Medical Devices·976 affected·Apr 25, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gam...
Medical Devices·505 affected·Apr 25, 2013
High RiskFDA
The Anspach Effort, Inc.
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
Medical Devices·2,785 affected·Apr 25, 2013
High RiskFDA
Instratek, Incorporated
Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
Medical Devices·96 affected·Apr 25, 2013
High RiskFDA
Early Bird Foods & Co., Llc
Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic ba...
Bakery & Grains·57 affected·Apr 24, 2013
High RiskFDA
Insight Instruments, Inc.
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd....
Drugs·316,464 affected·Apr 24, 2013
High RiskFDA
Embla System Llc
embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operat...
Respiratory Devices·519 affected·Apr 24, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the pall...
Medical Implants·23 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is ind...
Medical Implants·784 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is ind...
Medical Implants·310 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is ind...
Medical Implants·250 affected·Apr 23, 2013
High RiskFDA
Cordis Corporation
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the pall...
Medical Implants·1,357 affected·Apr 23, 2013
High RiskFDA
Alfred Louie Inc
Soy Bean Sprouts: Keep Refrigerated: Ingredients:Soy Beans Net WT: 5 lbs (2.27 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product ...
Food·0 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Drugs·2 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
Injectable Drugs·8 affected·Apr 22, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·3,048 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Drugs·0 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Injectable Drugs·0 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Injectable Drugs·1 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
Injectable Drugs·0 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
Injectable Drugs·0 affected·Apr 22, 2013