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High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Medical Devices·1,785 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Medical Implants·50 affected·Mar 9, 2020
High RiskFDA
Abbott Gmbh & Co. Kg
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Diagnostic Devices·7,347 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Medical Devices·5,565 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
Medical Implants·2 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Medical Implants·57 affected·Mar 9, 2020
High RiskFDA
Meijer Inc.
Meijer Mixed Nuts with Peanuts & Sea Salt 16 Oz UPC: 7-19283-80863-9
Food·8,200 affected·Mar 6, 2020
High RiskFDA
Dean Foods, Inc.
Baskin Robbins Mint Chocolate Chip, Ice Cream Sandwiches with Mint Ice Cream, Semi-Sweet Chocolate Chips & Chocolate Wafers 4 Pack; 4 3...
Dairy·46,980 affected·Mar 6, 2020
High RiskFDA
Nostrum Laboratories Inc
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas...
Oral Drugs·4,722 affected·Mar 6, 2020
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bo...
Oral Drugs·11,973 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal c...
Cardiac Devices·2 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorpor...
Cardiac Devices·15 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique a...
Cardiac Devices·10 affected·Mar 6, 2020
High RiskFDA
R82 A/s
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Medical Devices·2,230 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal ci...
Cardiac Devices·38 affected·Mar 6, 2020
High RiskFDA
Stonewall Kitchen, Llc
Stonewall Kitchen, Ghost Pepper Salsa, Net Weight 454g (16oz), Ingredients: Tomatoes, Jalapeno Peppers, Onion, Tomato Puree, Green Chile ...
Produce·4,800 affected·Mar 5, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Injectable Drugs·32,592 affected·Mar 5, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA,...
Injectable Drugs·600 affected·Mar 5, 2020
High RiskFDA
Skytron, Div. The Kmw Group, Inc
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
Medical Devices·43 affected·Mar 5, 2020
High RiskFDA
Respironics California, Llc
Philips V60 Ventilators with Power Management PCBA part number 1055906
Respiratory Devices·23,581 affected·Mar 5, 2020
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Medical Devices·40 affected·Mar 5, 2020
High RiskFDA
Baxter Healthcare Corporation
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally en...
Surgical Devices·209 affected·Mar 5, 2020
High RiskFDA
Baxter Healthcare Corporation
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in micr...
Surgical Devices·0 affected·Mar 5, 2020
High RiskFDA
Philips North America, Llc
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Medical Devices·81,626 affected·Mar 5, 2020
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product U...
Medical Devices·1,389 affected·Mar 4, 2020
High RiskFDA
Tops Markets Inc.
Tops Mint Flavor Pure Dark Chocolate 45% Cocoa NET WT 3.5 oz.(100g)
Snacks & Candy·1,482 affected·Mar 3, 2020
High RiskFDA
Yusef Manufacturing Laboratories, Llc
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL ...
Drugs·12,983 affected·Mar 3, 2020
High RiskFDA
Capintec Inc
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Me...
Medical Devices·48 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·15 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·46 affected·Mar 3, 2020
High RiskFDA
Canon Medical System, Usa, Inc.
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system us...
Cardiac Devices·24 affected·Mar 3, 2020
High RiskFDA
Global Juices & Fruits Llc
Nature's Earthly Choice Organic Lentil Trio product containing a blend of red split, black and green lentils, labeled Gluten-Free, packag...
Food·5,070 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·11,093 affected·Mar 2, 2020
High RiskFDA
Mayne Pharma Inc
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
Oral Drugs·8,274 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·7,469 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·9,513 affected·Mar 2, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for N...
Topical Drugs·13,761 affected·Mar 2, 2020
High RiskFDA
Merits Holdings Co. Dba Merits Health Products, Inc.
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Medical Devices·82 affected·Mar 2, 2020
High RiskFDA
Csl Behring Gmbh
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Num...
Medical Devices·297 affected·Mar 2, 2020
High RiskFDA
Sunstar Guangzhou Ltd.
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Drugs·260,000 affected·Feb 28, 2020
High RiskFDA
Snow's Acquisition, Llc
Barts Ice Cream Co. brand of Chocolate Chip Cookie Dough ice cream (Vanilla ice cream with chunks of cookie dough and dark chocolate chip...
Dairy·1,064 affected·Feb 27, 2020
High RiskFDA
Pfizer Inc.
Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. ...
Injectable Drugs·24,714 affected·Feb 27, 2020
High RiskFDA
Cme America Llc
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* ...
Medical Devices·27 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated ...
Medical Devices·20,025 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimic...
Medical Devices·6,395 affected·Feb 27, 2020
High RiskFDA
Smith & Nephew, Inc.
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used ...
Medical Devices·348 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated G...
Medical Devices·53,134 affected·Feb 27, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Medical Devices·1,807 affected·Feb 27, 2020