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High RiskFDA
Sundial Herbal Products
"SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALA...
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Worms & Parasites***" packaged in boxes
Baby Food & Formula·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"***Sundial***ASHANTI**WEIGHT LOSS ENERGY LIFTER and APPETITE SUPPRESSER***" packaged in glass bottles
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"SUNDIAL***COCOA BALLS***" packaged in translucent plastic bags
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLACK SAGE***1 oz.***USES: ALZHEIMER'S DISEASE, GINGIVITIS, MENOPAUS...
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CHANEY ROOT***2oz.***USES: BLOOD CLEANSER, SKIN PROBLEMS, SYPHILIS, RHE...
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***DEVIL HORSEWHIP***1 oz.***USES: COUGH, COLD, CHEST PAIN,***FEVER, VE...
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PISS A BED***1 oz.***USES: LIVER TONIC, ARTHRITIS, RHEUMATISM, KIDNE...
Food·0 affected·Jun 30, 2020
High RiskFDA
Sundial Herbal Products
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE POND LILY***1oz.***USES: CANCER, DOUCHE, TUBERCULOSIS IN LYMPH...
Food·0 affected·Jun 30, 2020
High RiskFDA
Teleflex Medical Inc
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the...
Medical Devices·1,812 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming ...
Medical Devices·130,612 affected·Jun 30, 2020
High RiskFDA
Hill-rom, Inc.
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated wit...
Medical Devices·257 affected·Jun 30, 2020
High RiskFDA
Medline Industries Inc
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are inte...
Surgical Devices·680 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of ...
Medical Devices·1,442,097 affected·Jun 30, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Medical Devices·1,800 affected·Jun 30, 2020
High RiskFDA
Carefusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the ...
Medical Devices·8,558 affected·Jun 30, 2020
High RiskFDA
Philips North America, Llc
IntelliVue MX800 patient monitor, model no. 865240
Medical Devices·28 affected·Jun 30, 2020
High RiskFDA
Garland Ventures, Ltd Dba Bally Plus
Freshness Guaranteed Five Cheese Stuffed Shells Traditional Italian Ricotta Filled Shells with Marinara Sauce 10.76 ounces UPC 7874235174
Dairy·1,095 affected·Jun 29, 2020
High RiskFDA
Emd Serono, Inc.
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., R...
Injectable Drugs·30,756 affected·Jun 29, 2020
High RiskFDA
Remedyrepack Inc.
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489...
Oral Drugs·498 affected·Jun 29, 2020
High RiskFDA
Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patien...
Medical Devices·3 affected·Jun 29, 2020
High RiskFDA
Boss Instruments, Ltd.
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are s...
Medical Devices·96 affected·Jun 26, 2020
High RiskFDA
Precision Valve & Automation,inc
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motor...
Respiratory Devices·3 affected·Jun 26, 2020
High RiskFDA
Covidien Llc
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp style...
Medical Devices·269 affected·Jun 26, 2020
High RiskFDA
Chuckanut Bay Foods Llc
Red Velvet Layered Cheesecake is one whole cake (9" round cake) that has been pre-sliced into 14 slices and packaged in a white case box....
Dairy·60 affected·Jun 25, 2020
High RiskFDA
Polarized Llc
Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, M...
Drugs·18 affected·Jun 25, 2020
High RiskFDA
Built Brands Llc
Banana Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes,...
Snacks & Candy·79,500 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Double Chocolate Mousse Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes...
Snacks & Candy·48,480 affected·Jun 24, 2020
High RiskFDA
Whole Foods Market
Whole Foods Market Red Velvet Layered Cheesecake Slice PLU: 78620 packaged in plastic clam shell with scale label applied
Dairy·287 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Banana Nut Bread Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net w...
Bakery & Grains·333,420 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Black Cherry Chocolate Creme Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count ...
Snacks & Candy·121,190 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Cookie Dough Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. r...
Bakery & Grains·63,020 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Cashew Caramel with Coconut Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count b...
Snacks & Candy·33,930 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Toffee Almond Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ...
Snacks & Candy·169,670 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
S'Mores Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges...
Snacks & Candy·58,170 affected·Jun 24, 2020
High RiskFDA
Built Brands Llc
Peanut Butter Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ...
Dairy·242,400 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to hel...
Medical Devices·12 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
SUTUREFIX ULTRA Suture, Product number 72203855
Medical Devices·868 affected·Jun 24, 2020
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff re...
Surgical Devices·137 affected·Jun 24, 2020
High RiskFDA
Arthrex, Inc.
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone...
Medical Devices·28 affected·Jun 24, 2020
High RiskFDA
Power Selles Imports Dba Culinary Collective
Blanxart 85% Nicaragua Organic Dark Chocolate Bar, packaged in paper packaging with internal foil wrapper. Net weight 4.4 oz (125 g). UPC...
Dairy·72 affected·Jun 23, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Medical Devices·8 affected·Jun 23, 2020
High RiskFDA
Chengdu Ai Qin E-commerce Co., Ltd
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Medical Devices·0 affected·Jun 23, 2020
High RiskFDA
Biosense Webster (israel), Ltd.
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardi...
Cardiac Devices·0 affected·Jun 22, 2020
High RiskFDA
Ge Healthcare, Llc
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to...
Medical Devices·8,414 affected·Jun 22, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional...
Cardiac Devices·4 affected·Jun 20, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional...
Cardiac Devices·5 affected·Jun 20, 2020
High RiskFDA
Fresh Express Incorporated
Little Salad Bar Garden, 12 oz, UPC 4099100082975, Iceberg lettuce, carrots & red cabbage
Produce·0 affected·Jun 19, 2020