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High RiskFDA
Boston Scientific Corporation
Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
Medical Implants·54 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·820 affected·Oct 21, 2019
High RiskFDA
Haemonetics Corporation
CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recov...
Medical Devices·1,092 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·16 affected·Oct 21, 2019
High RiskFDA
Boston Scientific Corporation
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
Medical Implants·940 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·0 affected·Oct 21, 2019
High RiskFDA
Haemonetics Corporation
CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery ...
Medical Devices·333,443 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·0 affected·Oct 21, 2019
High RiskFDA
Talley Farms
Arroyo Grande California Cilantro; Talley Farms; Product of USA - 30 or 60 Count Individual bunches tied with Talley Farms Arroyo Grand...
Food·8,436 affected·Oct 18, 2019
High RiskFDA
Cold Locker Processing Llc
Kroger Wild Caught Sockeye Salmon Boneless, Frozen, Raw, Skin-on, not ready to eat (NRTE), individually vacuum packed in a 12 oz retail p...
Seafood·2,520 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.
Drugs·0 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, ...
Drugs·598 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
Drugs·1,000 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, T...
Drugs·949 affected·Oct 18, 2019
High RiskFDA
Mylan Pharmaceuticals Inc.
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Oral Drugs·4,272 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonvil...
Drugs·98 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonvill...
Drugs·554 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN ...
Drugs·25 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Henderson...
Drugs·339 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
Drugs·25 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
Drugs·25 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset H...
Drugs·391 affected·Oct 18, 2019
High RiskFDA
Cp Medical Inc
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
Medical Devices·174 affected·Oct 18, 2019
High RiskFDA
Brasseler Usa I Lp
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill...
Medical Devices·387 affected·Oct 18, 2019
High RiskFDA
Basic Reset Inc.
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Medical Devices·1,257 affected·Oct 18, 2019
High RiskFDA
Tornier, Inc
Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386...
Medical Implants·87,869 affected·Oct 18, 2019
High RiskFDA
Harris Teeter Supermarkets, Llc Dba Hunter Farms
THE FRESH MARKET Mint Chip OLD FASHIONED ICE CREAM 1.5 QT (1.42 L) container DISTRIBUTED BY: THE FRESH MARKET GREENSBORO, NC 27406 UPC 7 ...
Dairy·2,500 affected·Oct 17, 2019
High RiskFDA
Harris Teeter Supermarkets, Llc Dba Hunter Farms
Harris Teeter PREMIUM SELECTIONS CHOCOLATE SATISFACTION ICE CREAM 1.5 QT (1.42L) container PROUDLY DISTRIBUTED BY: HARRIS TEETER. LLC, MA...
Dairy·8,325 affected·Oct 17, 2019
High RiskFDA
Harris Teeter Supermarkets, Llc Dba Hunter Farms
Mint Chocolate Chip Ice Cream 1.5 QT (1.42L) container sold under the brand names of Harris Teeter ALL NATURAL, PROUDLY DISTRIBUTED BY: H...
Dairy·10,591 affected·Oct 17, 2019
Medium RiskFDA
Sandoz Inc
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laborator...
Ophthalmic Drugs·346,929 affected·Oct 17, 2019
RecallFDA
Sandoz Inc
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc...
Ophthalmic Drugs·76,644 affected·Oct 17, 2019
High RiskFDA
Avkare Inc.
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pul...
Oral Drugs·7,293 affected·Oct 17, 2019
High RiskFDA
Avkare Inc.
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pul...
Oral Drugs·1,351 affected·Oct 17, 2019
Medium RiskFDA
Sandoz Inc
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b)...
Topical Drugs·346,929 affected·Oct 17, 2019
High RiskFDA
Gilster-mary Lee Corp.
Food Lion Creamy Chocolate Frosting, Net Wt 16 OZ, Distributed by Food Lion, LLC, Salisbury, NC, foodlion.com, packaged in 12 cans per case.
Snacks & Candy·66 affected·Oct 16, 2019
RecallFDA
Epic Enterprises, Incorporated
Dr. Pepper 24 pack of 12 FL OZ Cans (288 FL OZ) in cardboard cases: Produced under the authority of Dr. Pepper/Seven Up, Inc., 5301 Legac...
Produce·1,703 affected·Oct 16, 2019
RecallFDA
Amneal Pharmaceuticals, Inc.
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharm...
Oral Drugs·2,460 affected·Oct 16, 2019
High RiskFDA
Coopersurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
Surgical Devices·4 affected·Oct 16, 2019
High RiskFDA
Abbott Point Of Care Inc.
i-STAT cTnI cartridge
Medical Devices·3,465,875 affected·Oct 16, 2019
High RiskFDA
Coopersurgical, Inc.
Quantam 2000 Electrosurgical Generator, Part number 909075.
Surgical Devices·105 affected·Oct 16, 2019
High RiskFDA
Philips North America, Llc
HeartStart XL+ Defibrillator/Monitor, Model 861290
Cardiac Devices·23,749 affected·Oct 16, 2019
CriticalFDA
Peekay International, Inc.
Bulk Dry Apricot in clear plastic bags inside brown cardboard box and Swan brand Dry Appricot & Keshav brand Dry Apricot in 7oz and 14oz ...
Food·7 affected·Oct 15, 2019
High RiskFDA
Alfa International Seafood Inc
Full Moon Fish Tuna Steaks, Skinless, Boneless, IVP, Size: 8 oz, Net Weight 5 lbs
Seafood·6 affected·Oct 15, 2019
High RiskFDA
Citrus World, Inc.
Disney Donald Duck Kiwi Strawberry Flavored Four Juice Cocktail 20 OZ
Beverages·254,376 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.
Drugs·3 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069...
Drugs·8 affected·Oct 15, 2019
High RiskFDA
8046255 Canada Inc. Dba Viatrexx
Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-0...
Drugs·69 affected·Oct 15, 2019