Skip to main content
High RiskFDA
Avkare Inc.
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 384...
Oral Drugs·15,678 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·934 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·10,441 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·2,144 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Respiratory Devices·38,990 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·9,863 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·46,313 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·534 affected·Oct 30, 2020
High RiskFDA
Neocis, Inc.
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (...
Medical Devices·100 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respir...
Respiratory Devices·3,887 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Medical Devices·17,110 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironi...
Respiratory Devices·481 affected·Oct 30, 2020
High RiskFDA
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Medical Devices·24,338 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironic...
Respiratory Devices·3 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·835 affected·Oct 30, 2020
High RiskFDA
Respironics California, Llc
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics...
Respiratory Devices·3,453 affected·Oct 30, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for pati...
Medical Devices·148 affected·Oct 29, 2020
High RiskFDA
Chromsystems Instruments & Chemicals Gmbh
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor ...
Medical Devices·850 affected·Oct 29, 2020
High RiskFDA
Homestead Creamery, Inc.
Lemonade 1/2 gallon glass bottle. UPC:7525200265. "10% Real Juice Lemonade"
Beverages·1,344 affected·Oct 28, 2020
High RiskFDA
Art Of Tea
Art Of Tea - Feel Better tea; Produced and Distributed by: Art of Tea LLC, Monterey Park, CA Directions: 1 Tbsp of tea in 8 oz. of...
Beverages·77 affected·Oct 28, 2020
High RiskFDA
Teva Pharmaceuticals Usa
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort ...
Oral Drugs·133,829 affected·Oct 28, 2020
High RiskFDA
Vitamin Cottage Natural Foods Market, Inc Dba Natural Grocers
Natural Grocers, Elderberries Whole Organic, 4 oz. (113g), plastic bag, UPC 0-0082-00304-3
Produce·7,738 affected·Oct 27, 2020
High RiskFDA
Celtrade Canada
Pacific Jade Indian Curry Sauce Starter With Fenugreek and Cardamom, wholesale case with 2, 39 oz. plastic tubs, case UPC 50758108742487
Food·153 affected·Oct 27, 2020
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila H...
Oral Drugs·6,840 affected·Oct 27, 2020
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila H...
Oral Drugs·7,908 affected·Oct 27, 2020
High RiskFDA
Ge Healthcare, Llc
MAC VU360, Electrocardiograph
Medical Devices·5,284 affected·Oct 27, 2020
High RiskFDA
Philips Ultrasound Inc
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Af...
Diagnostic Devices·57,430 affected·Oct 27, 2020
High RiskFDA
Ascent Pharmaceuticals, Inc.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, ...
Oral Drugs·9,768 affected·Oct 26, 2020
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kan...
Oral Drugs·20,872 affected·Oct 23, 2020
High RiskFDA
Nostrum Laboratories Inc
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kan...
Oral Drugs·12,967 affected·Oct 23, 2020
High RiskFDA
Mako Surgical Corporation
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA ...
Medical Devices·367 affected·Oct 23, 2020
High RiskFDA
Medtronic Heart Valves Division
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLU...
Medical Devices·71,030 affected·Oct 23, 2020
High RiskFDA
Intuitive Surgical, Inc.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter with...
Surgical Devices·454 affected·Oct 23, 2020
High RiskFDA
Hardy Diagnostics
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic...
Medical Devices·686,920 affected·Oct 23, 2020
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidat...
Medical Implants·8,962 affected·Oct 23, 2020
High RiskFDA
Biomeme, Inc.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplificat...
Respiratory Devices·105 affected·Oct 23, 2020
High RiskFDA
Medtronic Heart Valves Division
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS...
Medical Devices·19,961 affected·Oct 23, 2020
High RiskFDA
Hubo International Inc
VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
Medical Devices·28,450 affected·Oct 23, 2020
High RiskFDA
H & H Remedies, Llc
Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 Sou...
Topical Drugs·252 affected·Oct 21, 2020
High RiskFDA
H & H Remedies, Llc
White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadw...
Drugs·365 affected·Oct 21, 2020
High RiskFDA
H & H Remedies, Llc
Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LL...
Drugs·939 affected·Oct 21, 2020
High RiskFDA
Coltene Whaledent Inc
CEI Cutting Edge Instruments (PTC-57C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
FG 57 100057X (100057X)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
Alpen Clinic 100 Carbide Instruments (R100057C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Coltene Whaledent Inc
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Medical Devices·556 affected·Oct 20, 2020
High RiskFDA
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology...
Medical Implants·537 affected·Oct 19, 2020
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients ...
Medical Devices·8 affected·Oct 19, 2020
High RiskFDA
Starwest Botanicals, Inc
Elderberry Whole Organic; Sambucus Nigra; Origin: Croatia 1 lb. and 4 oz. Distributed in Mylar bags. 1 lb. UPC: 7 67963 07315 0; It...
Beverages·10,037 affected·Oct 16, 2020