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High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis...
Injectable Drugs·3 affected·Feb 21, 2019
High RiskFDA
Arthrocare Corporation
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Medical Devices·15,559 affected·Feb 21, 2019
High RiskFDA
Meijer
Meijer Ultimate Chocolate Mint Chip Cookie Cookies in clear plastic clamshell 12 count UPC 4125014563 20 count UPC 4125014564
Bakery & Grains·12 affected·Feb 20, 2019
High RiskFDA
Vi-jon, Inc.
Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discoun...
Oral Drugs·6,756 affected·Feb 20, 2019
High RiskFDA
Abbott Laboratories
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic us...
Diagnostic Devices·6,353 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitativ...
Diagnostic Devices·267 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualita...
Diagnostic Devices·45 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·55 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, sem...
Diagnostic Devices·4 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qu...
Diagnostic Devices·25 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantita...
Diagnostic Devices·62 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Luminex Corporation
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Diagnostic Devices·0 affected·Feb 20, 2019
High RiskFDA
Southern Specialties, Inc
Marketside BUTTERNUT SQUASH CUBES 16 OZ (1LB) 454g
Dairy·360 affected·Feb 19, 2019
High RiskFDA
Southern Specialties, Inc
Sugar Snap Peas 10 LB
Food·990 affected·Feb 19, 2019
High RiskFDA
Leiter's Enterprises, Inc.
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) ...
Injectable Drugs·569 affected·Feb 19, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Medical Devices·9 affected·Feb 19, 2019
High RiskFDA
Philips Medical Systems Nederlands
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Serie...
Diagnostic Devices·7,209 affected·Feb 19, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Medical Devices·58 affected·Feb 19, 2019
High RiskFDA
The Binding Site Group, Ltd.
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determ...
Diagnostic Devices·10 affected·Feb 19, 2019
High RiskFDA
Philips Medical Systems Nederlands
Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005...
Diagnostic Devices·7,209 affected·Feb 19, 2019
High RiskFDA
Tedan Surgical Innovations Llc
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Scre...
Medical Devices·199 affected·Feb 18, 2019
High RiskFDA
Bard Peripheral Vascular Inc
LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP ...
Medical Implants·127 affected·Feb 18, 2019
High RiskFDA
Tedan Surgical Innovations Llc
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and ...
Medical Devices·57 affected·Feb 18, 2019
High RiskFDA
Concord Foods, Llc
Concord Fresh Success Mild Salsa Seasoning Mix, Packaged in a NET WT 1.05 OZ (30g) packet, UPC: 0 4140900229 5
Food·1,069 affected·Feb 16, 2019
High RiskFDA
Nita Foods Inc.
Nita Crisp Spelt Bread Cracker, 8- & 16-ounce bags, In paper bags with a plastic window and has a re-closable ability and safety sealed...
Bakery & Grains·210 affected·Feb 15, 2019
High RiskFDA
Nature's Path Foods Inc
Nature's Path Organic Chocolate Choco Chimps Organic cereal. Net Wt. 10 oz (284 g), UPC 58449-87024. Nature's Path Foods, Inc., Blaine,...
Bakery & Grains·9,242 affected·Feb 15, 2019
High RiskFDA
Nature's Path Foods Inc
Nature's Path Organic Gorilla Munch Corn Puffs cereal. Net Wt. 10 oz (284 g), UPC 58449-86002. Nature's Path Foods, Inc., Blaine, WA 9...
Bakery & Grains·23,969 affected·Feb 15, 2019
High RiskFDA
Nature's Path Foods Inc
Nature's Path Organic Cinnamon Jungle Munch cereal. Net Wt. 10 oz (284 g), UPC 58449-87028. Nature's Path Foods, Inc., Blaine, WA 98230.
Bakery & Grains·1,463 affected·Feb 15, 2019
High RiskFDA
Gasco Industrial, Corp.
Gasc¿ Golden Egg Yellow Shade Food Color, Contains: 32 fl. oz. (946 mL)
Food·135 affected·Feb 15, 2019
High RiskFDA
Gasco Industrial, Corp.
Gasc¿ Tomato Red Food Color, Net Contents: 5 gal (640 fl. oz)
Produce·35 affected·Feb 15, 2019
High RiskFDA
Heritage Pharmaceuticals, Inc.
Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in Ind...
Injectable Drugs·11,888 affected·Feb 15, 2019
High RiskFDA
Covidien Llc
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Medical Devices·25 affected·Feb 15, 2019
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: Th...
Diabetes Devices·186 affected·Feb 15, 2019
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, In...
Injectable Drugs·0 affected·Feb 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Us...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Acell, Inc
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended ...
Medical Implants·1 affected·Feb 14, 2019
High RiskFDA
Acell, Inc
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended ...
Medical Implants·1 affected·Feb 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sect...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Friendly Fruit Market Dba Sid Wainer & Son
JANSAL VALLEY DUKKAH NET WT 2.5 oz. (71 G). The product is packaged in a circular tin can with a clear lid. UPC: 7 08152 31773 0.
Food·27 affected·Feb 13, 2019
High RiskFDA
Smoked Alaska Seafoods
Smoked Silver Salmon, brand Smoked Alaska, packaged in 6.5 oz. glass jars or cans. The product label is read in parts: "***SMOKED WIL...
Seafood·661 affected·Feb 13, 2019
High RiskFDA
Bioventus, Llc
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to ...
Medical Devices·10,793 affected·Feb 13, 2019
High RiskFDA
Gold Coast Bakery
Aldi Bake Shop Lemon Loaf Cake 16 oz clear clam shell, 6 per tray (each tray includes 6 lemon loaf and 6 banana loaf) UPC 4099100018523
Bakery & Grains·3,240 affected·Feb 12, 2019