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RecallFDA
Linet Americas
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search ...
Medical Devices·202 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
RecallFDA
Par Pharmaceutical Inc.
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Oral Drugs·13,008 affected·Mar 4, 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
CriticalFDA
Vita Food Products, Inc.
Vita Wild Herring in Wine Sauce 32oz plastic jar, UPC 22635 40011, 6 jars per case Ready to Eat Keep Refrigerated
Food·8,370 affected·Mar 3, 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
CriticalFDA
New Capstone, Inc
ReStructure VANILLA PROTEIN POWDER NET WT. 527G POUCH & 27G SINGLE PACKET Other Ingredients: Non-GMO rBGH-Free Whey Protein Concentrate, ...
Food·3,235 affected·Mar 2, 2020
CriticalFDA
Whole Foods Market
Whole Foods Market Green Chile Chicken Tamale served as a Family Meal, Chef's Case, Packaged, Frozen and on he hot bar PLU 72429 packaged...
Meat & Poultry·2,270 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
CriticalFDA
Argo Medical Technologies Ltd
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is inte...
Medical Devices·350 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
RecallFDA
Dana Usa Corp.
Sunshine Spice DRIED SHRI SKIN TRI TRI, Weight (lb) 0.215
Food·25 affected·Feb 27, 2020
RecallFDA
Dana Usa Corp.
DION DION DRIED MUSHROOMS, Product Origin from Haiti, Net Wt. 1/4 oz
Food·25 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
RecallFDA
The Harvard Drug Group
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampu...
Oral Drugs·1 affected·Feb 27, 2020
RecallFDA
The Harvard Drug Group
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampu...
Oral Drugs·0 affected·Feb 27, 2020
RecallFDA
The Harvard Drug Group
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampu...
Oral Drugs·115 affected·Feb 27, 2020
RecallFDA
The Harvard Drug Group
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur...
Oral Drugs·330 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
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adul...
Diagnostic Devices·6 affected·Feb 27, 2020
High RiskFDA
Gentell, Inc
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated ...
Medical Devices·6,433 affected·Feb 27, 2020
CriticalFDA
Choice Products Llc.
Premiere Choice 3lb. Peanut Butter Cookie Dough, item 412, Net Wt. 48 oz (1360g) UPC 6 98240 00412 6. Made by: Club's Choice Fundraisi...
Dairy·275 affected·Feb 26, 2020