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High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropyle...
Topical Drugs·473,280 affected·Feb 19, 2021
High RiskFDA
Noven Pharmaceuticals Inc
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene...
Topical Drugs·786,900 affected·Feb 19, 2021
High RiskFDA
Bakeryworks Llc
UnTortillas Grain Free * 3 g of non-fibre carbs * 210g 6 tortillas per bag, 8 packages per case. UPC# 40628250179024 packaged in flexibl...
Food·471 affected·Feb 18, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemi...
Medical Devices·7,546 affected·Feb 18, 2021
High RiskFDA
Teleflex Medical Inc
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during trache...
Medical Devices·157 affected·Feb 18, 2021
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Medical Devices·496 affected·Feb 18, 2021
High RiskFDA
Giant Eagle
Market District Gourmet Pretzel Gift Bag PLU 45505 Net Wt 9 oz Market District Gourmet Pretzel Platter PLU 25206 Net Wt 48 oz
Food·192 affected·Feb 17, 2021
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 u...
Oral Drugs·1,350 affected·Feb 17, 2021
High RiskFDA
The General Hospital Corporation
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusett...
Injectable Drugs·50 affected·Feb 17, 2021
High RiskFDA
Vectornate Usa Inc
MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Produc...
Medical Devices·130,000 affected·Feb 16, 2021
High RiskFDA
Clerio Vision
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity...
Medical Devices·153 affected·Feb 16, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Pa...
Injectable Drugs·9,452 affected·Feb 15, 2021
High RiskFDA
Carestream Dental, Llc
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics ...
Medical Devices·11,400 affected·Feb 15, 2021
High RiskFDA
Litehouse Inc
Brite Harbor Caesar Dressing & Dip, 1.5 oz pillows (pouches), item # 16002. The front label states "***BRITE HARBOR CAESAR DRESSING & DI...
Dairy·225 affected·Feb 12, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination wi...
Diagnostic Devices·12,177 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-union...
Medical Devices·40 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unio...
Medical Devices·2,360 affected·Feb 12, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen...
Diagnostic Devices·2,782 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary ...
Medical Implants·229 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged E...
Medical Implants·59 affected·Feb 12, 2021
High RiskFDA
Nuvasive Specialized Orthopedics Inc
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, ...
Medical Devices·226 affected·Feb 12, 2021
High RiskFDA
Cardinal Health 200, Llc
JUDKINS PACK
Medical Devices·298 affected·Feb 11, 2021
High RiskFDA
Getinge Group Logistics America, Llc
Operating Table System
Medical Devices·4,288 affected·Feb 11, 2021
High RiskFDA
Hollister Incorporated
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a ...
Surgical Devices·1,031 affected·Feb 11, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 1945...
Injectable Drugs·12,609 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tr...
Injectable Drugs·29,357 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx ...
Injectable Drugs·26,373 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-0...
Injectable Drugs·2,577 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-...
Injectable Drugs·50 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials...
Injectable Drugs·336,697 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (...
Injectable Drugs·5,086 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tr...
Injectable Drugs·5,378 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wale...
Injectable Drugs·4,806 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 1945...
Injectable Drugs·12,629 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA,...
Injectable Drugs·15,043 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals US...
Injectable Drugs·0 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Man...
Injectable Drugs·705,745 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 07...
Injectable Drugs·248,565 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, ...
Injectable Drugs·6,710 affected·Feb 10, 2021
High RiskFDA
Dole Fresh Vegetables Inc
Dole Chopped Kit- Sunflower Crunch Cabbage, Green Leaf Lettuce, Kale, Sunflower Seeds, Sweet Onion and Citrus Dressing, Bacon Crumbles, ...
Produce·150 affected·Feb 9, 2021
High RiskFDA
Philips North America Llc
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Cardiac Devices·15 affected·Feb 9, 2021
High RiskFDA
In2bones, Sas
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Medical Devices·60 affected·Feb 9, 2021
High RiskFDA
Cardinal Health 200, Llc
McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids fr...
Medical Devices·108,000 affected·Feb 9, 2021
High RiskFDA
Cardinal Health 200, Llc
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids int...
Medical Devices·6,800 affected·Feb 9, 2021
High RiskFDA
Philips North America Llc
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Cardiac Devices·6 affected·Feb 9, 2021
High RiskFDA
Sharp Medical Products
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Medical Devices·129 affected·Feb 8, 2021
High RiskFDA
Meridian Bioscience Inc
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of ...
Medical Devices·8 affected·Feb 8, 2021
High RiskFDA
Mizuho Osi
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support...
Surgical Devices·26 affected·Feb 8, 2021