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High RiskFDA
Adler Micromed, Inc.
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. D...
Surgical Devices·1,858 affected·Apr 23, 2021
High RiskFDA
Coopersurgical, Inc.
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not m...
Medical Devices·6 affected·Apr 23, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Diagnostic Devices·156 affected·Apr 23, 2021
High RiskFDA
Wolfies Group Inc
Wolfie's Crunchy Cheddar & Jalapeno Peanuts Packaged in a Rice Paper Stand Up Pouch with Clear Poly Plastic Bag inside 5oz - 12 bags per ...
Food·266 affected·Apr 22, 2021
High RiskFDA
Abbott Laboratories Inc. (st Jude Medical)
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Medical Devices·318 affected·Apr 22, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8...
Medical Devices·13,722 affected·Apr 21, 2021
High RiskFDA
Potomac River Group, Corp.
RAPTAR Laser Range Finders
Medical Devices·62 affected·Apr 21, 2021
High RiskFDA
Dentech Corp.
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Medical Devices·87,842 affected·Apr 21, 2021
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide o...
Medical Devices·108 affected·Apr 21, 2021
High RiskFDA
Anodyne Surgical
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, R...
Surgical Devices·8,452 affected·Apr 21, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to T...
Diagnostic Devices·22,550 affected·Apr 21, 2021
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
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
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
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
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
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