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High RiskFDA
Siemens Healthcare Diagnostics, Inc
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Diagnostic Devices·390 affected·Feb 8, 2021
High RiskFDA
Ge Healthcare, Llc
NM/CT 860 Nuclear Medicine / CT Scanners
Medical Devices·242 affected·Feb 7, 2021
High RiskFDA
Shenandoah Growers, Inc.
Organic fresh cut basil packaged in plastic clamshell containers. Shenandoah Growers by Thats Tasty, 0.75 oz UPC: 7-68573-00101-4 Shenan...
Food·3,240 affected·Feb 5, 2021
High RiskFDA
Russ Davis Wholesale Inc
Kowalski's Buffalo Cauliflower Bites with Kowalski's Steakhouse Blue Dressing. Net Wt. 22 oz (1 lb. 6 oz) 624 g. UPC 95631-89341. Kee...
Food·109 affected·Feb 5, 2021
High RiskFDA
Vallarta Organic Llc
ALBAHACA ORGANICA/BASIL, 460 gm x Bag, 15 Bags
Food·46 affected·Feb 5, 2021
High RiskFDA
Encore Medical, Lp
DJO EMPOWR KNEE Femoral Sizer
Medical Devices·16 affected·Feb 5, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
System INFX-8000C
Medical Devices·272 affected·Feb 5, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
System INFX-8000F
Medical Devices·272 affected·Feb 5, 2021
High RiskFDA
Tropicana Products, Inc.
KeVita Cucumber Rosemary (primary package), 15.2 oz., glass bottles, 6 packages per case, refrigerated storage
Food·5,479 affected·Feb 4, 2021
High RiskFDA
Wilshire Pharmaceuticals Inc
Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product o...
Oral Drugs·2,112 affected·Feb 4, 2021
High RiskFDA
Wilshire Pharmaceuticals Inc
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of ...
Oral Drugs·35,928 affected·Feb 4, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequ...
Diagnostic Devices·1,172 affected·Feb 4, 2021
High RiskFDA
Barron County Organics
20 Mile Rhubarb, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48811. Made by Barron County Organics,...
Frozen Food·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Salted Chocolate Caramel Crunch, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48801. Made by...
Snacks & Candy·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Maple Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48806. Made by Barron County Organ...
Dairy·3,855 affected·Feb 3, 2021
High RiskFDA
Ocean Beauty Seafoods Llc
The RETAIL package is black cardboard box and product is described as: Publix Parmesan-Crusted Wild Alaskan Salmon Fillets, Frozen, net w...
Seafood·845 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Peach Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. Made by Barron County Organics, LLC, 10-Mil...
Dairy·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Black Cherry Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48807. Made by Barron County Org...
Frozen Food·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Dark Chocolate, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48805. Made by Barron County Or...
Snacks & Candy·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Chocolate Chip Cookie Dough, Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48803. Made by Ba...
Bakery & Grains·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Mint Chocolate Chip, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. Made by Barron County Organics, LLC...
Snacks & Candy·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Vanilla Bean Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48804. Made by Barron County Organ...
Frozen Food·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Holiday EggNog, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48815. Made by Barron County Or...
Frozen Food·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Raspberry, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48812. Made by Barron County Organic...
Produce·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Cookies-N-Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48802. Made by Barron County O...
Dairy·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Strawberry, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48813. Made by Barron County Organi...
Produce·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Salted Caramel with Cashew Praline, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48800. Made...
Frozen Food·3,855 affected·Feb 3, 2021
High RiskFDA
Barron County Organics
20 Mile Coffee, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48806. Made by Barron County Organics, ...
Beverages·3,855 affected·Feb 3, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as dia...
Diabetes Devices·4,174 affected·Feb 3, 2021
High RiskFDA
Somatex Medical Technologies Gmbh
Thread-like wire marker
Medical Devices·196 affected·Feb 3, 2021
High RiskFDA
Philips North America Llc
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for mon...
Medical Devices·3 affected·Feb 2, 2021
High RiskFDA
Alcon Research, Llc
Alcon Custom Ophthalmic Surgical Procedure Packs
Surgical Devices·249,853 affected·Feb 2, 2021
High RiskFDA
Kimberly-clark Corporation
Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, G...
Drugs·2,982 affected·Feb 1, 2021
High RiskFDA
Insulet Corporation
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Di...
Diabetes Devices·21,723 affected·Feb 1, 2021
High RiskFDA
Bovie Medical Corporation
ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during ...
Surgical Devices·5,270 affected·Feb 1, 2021
High RiskFDA
Epimed International, Inc.
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia an...
Surgical Devices·5,835 affected·Feb 1, 2021
High RiskFDA
Bovie Medical Corporation
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue durin...
Surgical Devices·5,894 affected·Feb 1, 2021
High RiskFDA
Thermo Fisher Scientific
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Medical Devices·19 affected·Feb 1, 2021
High RiskFDA
Kewpie Trading Europe B.v.
Kewpie Deep Roasted Sesame Dressing; 8 oz.(263ml/243g) and 64 oz. (1893 ml/1950g) bottles (glass and plastic) Refrigerate after openin...
Food·8 affected·Jan 31, 2021
High RiskFDA
Renaissance Food Group, Llc
BUFFALO STYLE CHICKEN Sliders NET WT. 5OZ (141g) Ingredients: Tuna Salad*** CONTAINS: EGG, FISH (TUNA), MILK, WHEAT Distributed By Renais...
Dairy·226 affected·Jan 29, 2021
High RiskFDA
Draeger Medical, Inc.
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conducti...
Respiratory Devices·25 affected·Jan 29, 2021
High RiskFDA
Getinge Group Logistics America, Llc
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients...
Respiratory Devices·144 affected·Jan 29, 2021
High RiskFDA
Stryker Communications
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series F...
Medical Devices·1,393 affected·Jan 29, 2021
High RiskFDA
Draeger Medical, Inc.
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduct...
Respiratory Devices·150 affected·Jan 29, 2021
High RiskFDA
Glanbia Performance Nutrition (manufacturing), Inc
think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumble bowl 1.76 oz. individual unit UPC 753656711836 also sold in retail 6 pack ...
Produce·81,906 affected·Jan 28, 2021
High RiskFDA
Treehouse Foods
Happy Belly Mayo Light Mayonnaise 30 FL OZ Plastic Jar Item B08B6T9RC6
Food·30 affected·Jan 28, 2021
High RiskFDA
Olympus Corporation Of The Americas
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equip...
Surgical Devices·1,564 affected·Jan 28, 2021
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Medical Devices·1,225 affected·Jan 28, 2021