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High RiskFDA
J And J Bunting, Inc
Kowalski's Markets kalbi rub. Net Wt 5.5 oz. (155.9 g), UPC 79147-00243. Distributed by: Kowalski's Markets, Woodbury, MN 55125
Food·117 affected·Jul 12, 2018
High RiskFDA
Kerry Inc
Soy Honey Cluster 30 lb. case, plastic bag in cardboard box Product code 30666529.137
Food·165,600 affected·Jul 12, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ...
Injectable Drugs·5,215 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Medical Devices·41 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Medical Devices·68 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Diagnostic Devices·7,880 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Medical Devices·37 affected·Jul 12, 2018
High RiskFDA
Zimmer Biomet, Inc.
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone frag...
Medical Devices·25 affected·Jul 12, 2018
High RiskFDA
Ultradent Products, Inc.
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk K...
Medical Devices·1,654 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Surgical Devices·0 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Surgical Devices·0 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Surgical Devices·0 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Surgical Devices·0 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
Diagnostic Devices·1,955 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Surgical Devices·0 affected·Jul 12, 2018
High RiskFDA
Orthosensor, Inc.
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Medical Devices·36 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Diagnostic Devices·1,790 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Surgical Devices·0 affected·Jul 12, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Diagnostic Devices·68,230 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Medical Devices·0 affected·Jul 12, 2018
CriticalFDA
Medical Components, Inc Dba Medcomp
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XT...
Surgical Devices·0 affected·Jul 12, 2018
RecallCPSC
Burton And Other Specialty Stores Nationwide And Online At Burton.com And Other Websites From November 2016 Through December 2017 For Between $300 And $400.
Burton Recalls Snowboard Boots Due to Fall Hazard (Recall Alert)
Consumer Products·4,800 affected·Jul 11, 2018
High RiskFDA
Papa John's Salads & Produce, Inc.
Superfood Salad Kit - 6.8 lbs. - sold to Kroger owned stores and prepared and purchased at deli department at retail stores. Size purcha...
Beverages·148 affected·Jul 11, 2018
High RiskFDA
Constantine's International Foods
JouJou's white large pita bread
Bakery & Grains·57 affected·Jul 11, 2018
RecallFDA
Renaissance Lakewood, Llc
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, R...
Injectable Drugs·12,088 affected·Jul 11, 2018
RecallFDA
Renaissance Lakewood, Llc
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, R...
Injectable Drugs·3,000 affected·Jul 11, 2018
RecallFDA
Renaissance Lakewood, Llc
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, R...
Injectable Drugs·3,664 affected·Jul 11, 2018
High RiskFDA
Pom Medical Llc
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med ...
Respiratory Devices·5,610 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Product...
Diagnostic Devices·128,196 affected·Jul 11, 2018
CriticalFDA
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This...
Respiratory Devices·328 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitr...
Diagnostic Devices·627,543 affected·Jul 11, 2018
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products ...
Diagnostic Devices·420,105 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Medical Devices·27,515 affected·Jul 11, 2018
RecallCPSC
Outdoor Specialty Stores, Ski Shops Nationwide And Direct To Avalanche Professionals, Search And Rescue Personnel And Mountain Guides From July 2010 Through April 2018 For About $350.
ORTOVOX Recalls Avalanche Transceivers Due to Loss of Emergency Communications Capability
Consumer Products·20,000 affected·Jul 10, 2018
High RiskFDA
Apogee Foods
Thunderbird Bars 1.15 oz Apple Pie Kid Bar (carton of 120)
Food·57 affected·Jul 10, 2018
High RiskFDA
Apogee Foods
Thunderbird Bars 1.7 oz Pecan Goji Pistachio Bar (case of 120)
Food·63 affected·Jul 10, 2018
High RiskFDA
Lenni's Crab Mix, Inc
Lenny's Maryland Crab Mix
Seafood·408 affected·Jul 10, 2018
RecallFDA
Valeant Pharmaceuticals North America Llc
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instru...
Topical Drugs·306 affected·Jul 10, 2018
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·5,507 affected·Jul 10, 2018
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·7,024 affected·Jul 10, 2018
RecallFDA
Mylan Pharmaceuticals Inc.
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 265...
Oral Drugs·28,436 affected·Jul 9, 2018
High RiskFDA
Sorin Crm Sas
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Medical Implants·16 affected·Jul 9, 2018
High RiskFDA
Merit Medical Systems, Inc.
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non...
Medical Devices·6 affected·Jul 9, 2018
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusio...
Medical Devices·47 affected·Jul 9, 2018
High RiskFDA
Sorin Crm Sas
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Medical Implants·10 affected·Jul 9, 2018
RecallUSDA
Afandina Halal
Afandina Halal Recalls Raw Chicken Products Produced Without Benefit of Inspection
Poultry·0 affected·Jul 9, 2018