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High RiskFDA
Cardiovascular Systems Inc
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive ...
Medical Devices·8 affected·Sep 14, 2017
High RiskFDA
C.r. Bard, Inc.
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 P...
Surgical Devices·44,640 affected·Sep 14, 2017
High RiskFDA
C.r. Bard, Inc.
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbe...
Surgical Devices·10,949,013 affected·Sep 14, 2017
High RiskFDA
Cardiovascular Systems Inc
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive ...
Medical Devices·8 affected·Sep 14, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee S...
Medical Implants·10 affected·Sep 14, 2017
High RiskFDA
Amgen, Inc.
Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL v...
Drugs·275,380 affected·Sep 13, 2017
High RiskFDA
Zimmer Biomet, Inc.
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Medical Devices·337 affected·Sep 13, 2017
High RiskFDA
Zimmer Biomet, Inc.
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Medical Devices·337 affected·Sep 13, 2017
High RiskFDA
The Metrix Company
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Medical Devices·50 affected·Sep 13, 2017
High RiskFDA
Vitamin Cottage Natural Food Markets, Inc.
Natural Grocers Organic Deglet Noor Dates, Target weight is 0.60 - 0.70 lb random weight package, Zip lock plastic bag.
Food·898 affected·Sep 12, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Medical Implants·3,119 affected·Sep 12, 2017
High RiskFDA
Zoll Manufacturing Corp.
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age ...
Medical Implants·33,670 affected·Sep 12, 2017
High RiskFDA
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60=ST
Medical Devices·4 affected·Sep 12, 2017
High RiskFDA
Terumo Medical Corporation
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to b...
Surgical Devices·33 affected·Sep 12, 2017
High RiskFDA
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60
Medical Devices·75 affected·Sep 12, 2017
High RiskFDA
Diversified Foods And Seasonings, Inc
Homestyle Broccoli and Cheese Soup, 1.66 lb Plastic boil-n-bag pouches, frozen, Contains: Milk, Soy, Wheat
Dairy·147 affected·Sep 11, 2017
High RiskFDA
United Therapeutics Corp.
TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, R...
Drugs·12 affected·Sep 11, 2017
High RiskFDA
Medtronic Inc.
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Medical Devices·5,842 affected·Sep 10, 2017
High RiskFDA
Apple King, Llc
Fuji apples, Nature's Delight brand, packaged in tray pack box size 64, net weight 40 lbs., PLU 4131, distributed by L&M Yakima, WA 98903
Food·11,801 affected·Sep 8, 2017
High RiskFDA
Howmedica Osteonics Corp.
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to i...
Medical Implants·130 affected·Sep 8, 2017
High RiskFDA
Handicare Usa Inc
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Medical Devices·8 affected·Sep 8, 2017
High RiskFDA
Limacorporate S.p.a
Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Medical Implants·20 affected·Sep 8, 2017
High RiskFDA
Sysmex America, Inc.
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sys...
Medical Devices·23,239 affected·Sep 8, 2017
High RiskFDA
Radiometer America Inc
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules a...
Medical Devices·1,669 affected·Sep 7, 2017
High RiskFDA
Coborn's, Inc
Coborn's/Cash Wise Caraway Rye Bread - UPC 7-33147-20155-8 Net Wt. 16 oz (1.0 lb) (454 g) Sell by 9/6/2017
Bakery & Grains·121 affected·Sep 6, 2017
High RiskFDA
Coborn's, Inc
Coborn's/Cash Wise American Rye Bread - UPC 7-33147-20150 Net Wt. 16 oz (1.0 lb) (454 kg) Sell by 9/7/2017
Bakery & Grains·121 affected·Sep 6, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Surgical Devices·329 affected·Sep 6, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Medical Devices·357 affected·Sep 6, 2017
High RiskFDA
Wegmans Food Markets, Inc.
Wegmans Assorted Muffins 4-Pack-18 oz. (1 lb. 2 oz.) 510g packaged in clear plastic shell. UPC: 77890-22744 .
Food·0 affected·Sep 5, 2017
High RiskFDA
Now Foods
Organic Coconut Sugar, 16oz bag, 12 bags/case, packed in a foil bag
Food·12,401 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc...
Drugs·22,080 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·96,828 affected·Sep 5, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by...
Oral Drugs·3,275 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·130,740 affected·Sep 5, 2017
High RiskFDA
Simple Diagnostics, Inc.
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC...
Drugs·150,250 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·29,232 affected·Sep 5, 2017
High RiskFDA
Llorens Pharmaceutical Corp.
Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate ...
Oral Drugs·19,232 affected·Sep 5, 2017
High RiskFDA
Aesculap Implant Systems Llc
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING ...
Medical Devices·6,211 affected·Sep 5, 2017
High RiskFDA
Aesculap Implant Systems Llc
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D...
Medical Devices·10,984 affected·Sep 5, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 126...
Drugs·534 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airpo...
Drugs·90 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W....
Injectable Drugs·60 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 30 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport...
Drugs·763 affected·Sep 1, 2017
High RiskFDA
Pfizer Inc.
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentec...
Injectable Drugs·18,725 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 40 units added to 1000 mL Lactated Ringer's USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport...
Drugs·42 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 ...
Injectable Drugs·1,308 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services, LLC. 1262...
Injectable Drugs·564 affected·Sep 1, 2017
High RiskFDA
Pharmedium Services, Llc
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 ...
Injectable Drugs·390 affected·Sep 1, 2017