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High RiskFDA
Health Solutions Pharmacy Center Inc Dba Professional Compounding Pharmacy
PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corva...
Injectable Drugs·2 affected·Feb 21, 2019
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
CriticalFDA
Icu Medical, Inc.
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration s...
Medical Devices·23,800 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed Syste...
Medical Devices·3,500 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed Sy...
Medical Devices·60,500 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed S...
Medical Devices·27,200 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave...
Medical Devices·300 affected·Feb 21, 2019
CriticalFDA
B&g Foods North America, Inc
Victoria Marinara Sauce, 40 oz. (2.5 lb) 1133g, 6Jars / Case
Food·1,280 affected·Feb 20, 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
CriticalFDA
Lean Culinary Services, Llc
DeliverLean Chicken Salad Triangle Sandwich, Net WT. 7.3 oz (206g)
Meat & Poultry·24 affected·Feb 20, 2019
CriticalFDA
Lean Culinary Services, Llc
DeliverLean Chicken Salad Hoagie, Net WT. 11.0 oz (311g)
Meat & Poultry·8 affected·Feb 20, 2019
CriticalFDA
Lean Culinary Services, Llc
The London Underground Classic Chicken Salad, Whole Foods Market, Net Wt 6.2 oz (176g)
Meat & Poultry·66 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
RecallFDA
Amerigen Pharmaceuticals Inc.
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: St...
Oral Drugs·2,413 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
RecallFDA
American Health Packaging
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, ...
Oral Drugs·14,360 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
RecallFDA
Beaver Visitec
Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and...
Surgical Devices·97 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