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High RiskFDA
Innovative Tomography Product Gmbh
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 1...
Medical Devices·0 affected·Apr 21, 2021
High RiskFDA
Innovative Tomography Product Gmbh
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length ...
Medical Devices·0 affected·Apr 21, 2021
CriticalFDA
Forest Mushroom Food Inc.
Guan's Enoki Mushroom - Champigons d'enoki; Net Wt./ Poids Net 200 g/ 7.05 oz.; 25 individual packages per box. Distributed by Guan's ...
Food·3,428 affected·Apr 20, 2021
High RiskFDA
Faribault Foods
O Organics Organic Black Beans, 15 oz. can, UPC 0-79893-40610-7 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009...
Food·619,761 affected·Apr 20, 2021
High RiskFDA
Faribault Foods
S&W Organic Black Beans, 15 oz. can, Distributed by: Faribault Foods, 3401 Park Ave NW, Faribault, MN 55021.
Food·619,761 affected·Apr 20, 2021
High RiskFDA
Faribault Foods
O Organics Organic Chili Beans, 15 oz. can, UPC 0-79893- 40617-6 Distributed by Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-000...
Food·619,761 affected·Apr 20, 2021
RecallFDA
Lopez Gonzalez Santana Corporation
BTREX PLUS, Dietary Supplement 100 Caplets
Supplements·311 affected·Apr 20, 2021
RecallFDA
Genentech Inc
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech,...
Oral Drugs·2,627 affected·Apr 20, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution...
Drugs·707,050 affected·Apr 20, 2021
High RiskFDA
Medivators, Inc.
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidne...
Medical Devices·1,381 affected·Apr 20, 2021
High RiskFDA
Elekta, Inc.
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Medical Devices·40 affected·Apr 20, 2021
High RiskFDA
Willowwood Global Llc
Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expu...
Medical Implants·815 affected·Apr 20, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Melatonin 140ct, 3 Pack 140 CT vitafusion Melatonin 44ct , 3Pack 44CT
Food·5,475 affected·Apr 19, 2021
High RiskFDA
Jkh Enterprises
Granny's Fudge Gorgeous Peanut Brittle, net wt. 5oz. or 8 oz, packed in a clear plastic container. No UPC. Label declares "***Ingredi...
Dairy·30 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Fiber Well 220ct, 10 / 220 CT
Food·2,928 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Muffin Tray 4 Cavity Large, Bake n Show¿ Muffin Tray 4 Cavity Large Shallow & Bake n Show¿ Muffin Tray 6 Cavity
Food·4 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Oven Ready Food Tray 16 ounce
Food·540 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion SleepWell 250ct / 24 / 250 CT
Food·120 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Pizza Cookie Tray 12"
Bakery & Grains·55 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Fiber Well 90ct, 4/3 Pack 90CT
Food·7,782 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion MultiVites 150ct,
Food·683 affected·Apr 19, 2021
High RiskFDA
Church & Dwight Co., Inc. Ogi Distribution Center
vitafusion Kids Melatonin 50ct, 4 / 3 PACK 50CT
Food·1,320 affected·Apr 19, 2021
High RiskFDA
Genpak
Bake n Show¿ Cake Tray Round & Bake n Show¿ Cake Tray Square
Bakery & Grains·55 affected·Apr 19, 2021
High RiskFDA
South Coast Baking Co.
SCB 12" Chocolate Chip Cookie Cake In CPET Tray with lid. Keep Frozen 0 Degrees F. Net Wt. 36.00 lbs. (16.33 kg) Case count: 25 Ite...
Dairy·1,096 affected·Apr 19, 2021
RecallFDA
Sigmapharm Laboratories Llc
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
Oral Drugs·6,266 affected·Apr 19, 2021
RecallFDA
Sigmapharm Laboratories Llc
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Oral Drugs·8,786 affected·Apr 19, 2021
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM a...
Medical Devices·33 affected·Apr 19, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7...
Medical Devices·139 affected·Apr 19, 2021
High RiskFDA
Ehob, Inc.
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed ...
Medical Devices·70 affected·Apr 19, 2021
CriticalFDA
Creative Foods Inc
Bueno Coffee Substitute Pecan Praline, Gluten-Free, net wt. 7 oz. (200g), UPC 6 79345 10010 4. INGREDIENTS: Simply Garbanzo Beans and Nat...
Beverages·1,519 affected·Apr 16, 2021
RecallFDA
Driscoll's Inc.
Driscoll's Fresh Blackberries; 6 oz. or 18 oz. containers.
Produce·109 affected·Apr 16, 2021
CriticalFDA
Creative Foods Inc
Bueno Coffee Substitute Creamy Hazelnut, Gluten-Free, net wt. 7 oz. (200g), UPC 6 79345 10020 3. INGREDIENTS: Garbanzo Beans (Chickpeas) ...
Beverages·1,341 affected·Apr 16, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 D...
Drugs·10,872 affected·Apr 16, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Flori...
Topical Drugs·12,060 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·2 affected·Apr 16, 2021
High RiskFDA
Hardy Diagnostics
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Medical Devices·69 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·34 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for...
Medical Devices·995 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or lon...
Respiratory Devices·18 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an ext...
Medical Devices·1,176 affected·Apr 16, 2021
High RiskFDA
Draeger Medical, Inc.
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or ...
Respiratory Devices·12 affected·Apr 16, 2021
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Diagnostic Devices·296 affected·Apr 16, 2021
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Medical Devices·9 affected·Apr 16, 2021
RecallUSDA
Unknown
JBS USA Food Company Recalls Imported Boneless Beef Products Due to Possible E. coli O157:H7 Contamination
Beef·0 affected·Apr 16, 2021
High RiskFDA
Grace Healthcare Medical, Inc
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Ga...
Drugs·35,838 affected·Apr 15, 2021
High RiskFDA
Vygon U.s.a.
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Medical Devices·8,320 affected·Apr 15, 2021
High RiskFDA
Flower Orthopedics Corporation
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T2...
Medical Devices·47 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposu...
Medical Devices·8,524 affected·Apr 15, 2021