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High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
Surgical Devices·3 affected·Mar 7, 2018
High RiskFDA
Paige Common
Maple Minis-Gluten Free, Donut Bites. Packaged in clam shell with label on top. 5 oz package. UPC 8 81314 32681 5. The product is read...
Dairy·46 affected·Mar 6, 2018
High RiskFDA
Josie's Homestyle Pralines Etc. Inc.
Josie's Homestyle #1 Pralines Net Wt. 2 oz (57 g) bag INGREDIENTS: Sugar, Cream, Pecans, Butter, Vanilla, if (Rum) Rum Flavoring. If (Coc...
Dairy·272 affected·Mar 6, 2018
High RiskFDA
Paige Common
Almond Love Bar - Vegan Chocolate Bar, wrapped in plastic wrap with label on top. 2.5 oz bar. UPC 0 91037 32678 2 The product is read...
Dairy·49 affected·Mar 6, 2018
High RiskFDA
Integra Lifesciences Corp.
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive ...
Medical Devices·766 affected·Mar 6, 2018
High RiskFDA
Idlife, Llc
IDLife Kids Bar Chocolate and Mixed Berry (SKU 16-0013) Organic, non-GMO, gluten-free and nut-free snack bar for children. Individually ...
Snacks & Candy·690 affected·Mar 5, 2018
High RiskFDA
New Seasons Market Llc
9 inch Asparagus and Goat Cheese Quiche, packaged in a cardboard box with a clear window. UPC # 2 52209 10599 8. The retail label is r...
Dairy·45 affected·Mar 5, 2018
High RiskFDA
Kodiak Cakes, Llc
Kodiak Cakes, Energy Waffles, Blueberry Chia, Net Wt 10.72 Oz (304 g), Kodiak Cakes, Park City, UT. Packaging configuration: 8-ct chipbo...
Bakery & Grains·34,816 affected·Mar 5, 2018
High RiskFDA
Idlife, Llc
IDLife Snack Bar Chocolate and Almond (SKU 16-0011) Organic, non-GMO and gluten-free snack bar. Individually wrapped bars, packaged 10 t...
Snacks & Candy·1,569 affected·Mar 5, 2018
High RiskFDA
Idlife, Llc
IDLife Protein Bar Chocolate and Peanut Butter (SKU 16-0012) Organic, non-GMO and gluten-free protein bar. Individually wrapped bars, pa...
Dairy·675 affected·Mar 5, 2018
High RiskFDA
Johnson Matthey Inc.
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West ...
Drugs·169 affected·Mar 5, 2018
High RiskFDA
Sagent Pharmaceuticals Inc
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Sch...
Injectable Drugs·205,370 affected·Mar 5, 2018
High RiskFDA
Sagent Pharmaceuticals Inc
methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Sc...
Injectable Drugs·48,964 affected·Mar 5, 2018
High RiskFDA
Sagent Pharmaceuticals Inc
methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Sc...
Injectable Drugs·176,410 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Diagnostic Devices·10,913 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Diagnostic Devices·4,027 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
Diagnostic Devices·4,867 affected·Mar 5, 2018
High RiskFDA
Synthes (usa) Products Llc
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Medical Devices·4 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
Diagnostic Devices·4,824 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
Diagnostic Devices·24,410 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
Diagnostic Devices·12,614 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
Diagnostic Devices·2,867 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
Diagnostic Devices·9,033 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing qual...
Diagnostic Devices·2,864 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
Diagnostic Devices·41,105 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Diagnostic Devices·14,690 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
Diagnostic Devices·15,942 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Diagnostic Devices·5,990 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
Cardiac Devices·2,549 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
Diagnostic Devices·12,361 affected·Mar 5, 2018
High RiskFDA
Synthes, Inc.
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure t...
Medical Devices·84 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
Diagnostic Devices·10,023 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
Diagnostic Devices·1,442 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
Diagnostic Devices·43,275 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative me...
Diabetes Devices·6,049 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
Diagnostic Devices·1,047 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
Diagnostic Devices·5,491 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
Diagnostic Devices·752 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Diagnostic Devices·3,254 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
Diabetes Devices·1,358 affected·Mar 5, 2018
High RiskFDA
Synthes (usa) Products Llc
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
Medical Devices·3 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
Diagnostic Devices·49 affected·Mar 5, 2018
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calib...
Diagnostic Devices·1,485 affected·Mar 5, 2018
High RiskFDA
Ripple Foods Pbc
ripple Chocolate Nutritious Pea Milk; 48 oz. plastic bottle; 8 g Plant Based Protein 30% Less Sugar than Chocolate Milk; 50% More Cal...
Dairy·448 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 80...
Diabetes Devices·2,225 affected·Mar 2, 2018
High RiskFDA
Getinge Disinfection Ab
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 073401537...
Medical Devices·170 affected·Mar 2, 2018