Skip to main content
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
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
Diagnostic Devices·1,955 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
High RiskFDA
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Diagnostic Devices·68,230 affected·Jul 12, 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
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
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
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
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
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
High RiskFDA
Earthrise Nutritionals Llc
Earthrise Natural Spirulina; Net Weight: 20.0 kg( 44.0 lbs); Double bag sealed - 1 bag per box. UPC: 0 32602 99040 3
Food·1,014 affected·Jul 6, 2018
High RiskFDA
3m Company - Health Care Business
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish ...
Medical Devices·73 affected·Jul 6, 2018
High RiskFDA
Neotract Inc
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By:...
Medical Devices·8,804 affected·Jul 6, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING POMEGRANETE JUICE DRNK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING MANDARIN JUICE DRINK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Ywam Faith Harvest Helpers
Canned Salmon in unlabeled 8oz metal cans. Cans are packaged into a case of 92 cans. The case label is read: "Canned Salmon***Product ...
Seafood·4,818 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING GRAPEFRUIT JUICE DRINK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING SOUR CHERRY JUICE DRINK, 6/34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING LEMON JUICE DRINK , 6 /34 oz., glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
Gourmet International Inc.
SPARKLING LIME JUICE DRINK, 6/34 oz, glass bottles
Beverages·403 affected·Jul 5, 2018
High RiskFDA
The Hain Celestial Group, Inc. - Worldwide Hq
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per ...
Drugs·47,128 affected·Jul 5, 2018
High RiskFDA
Sanofi-aventis U.s. Llc
Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Phy...
Injectable Drugs·3,214 affected·Jul 5, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake Ci...
Topical Drugs·27,803 affected·Jul 5, 2018
High RiskFDA
Ctl Medical Corporation
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Medical Devices·133 affected·Jul 5, 2018
High RiskFDA
Medgyn Products, Inc.
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: M...
Drugs·2,750 affected·Jul 3, 2018
High RiskFDA
Medi-fare Drug And Home Health Center
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West...
Injectable Drugs·1,116 affected·Jul 3, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutica...
Oral Drugs·2,508 affected·Jul 3, 2018
High RiskFDA
Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Medical Devices·2,131 affected·Jul 3, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by ...
Medical Devices·23 affected·Jul 3, 2018
High RiskFDA
Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage:...
Surgical Devices·166 affected·Jul 3, 2018
High RiskFDA
Convatec, Inc
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile...
Surgical Devices·3,881 affected·Jul 3, 2018
High RiskFDA
Abbott Vascular
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with intervention...
Medical Implants·26 affected·Jul 3, 2018
High RiskFDA
Hudson Scientific Llc
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the soft...
Medical Devices·35,949 affected·Jul 2, 2018
High RiskFDA
Cypress Medical Products Llc
Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers ...
Medical Devices·66 affected·Jul 2, 2018
High RiskFDA
Sca Pharmaceuticals
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only ,...
Injectable Drugs·3,984 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices·107 affected·Jun 29, 2018
High RiskFDA
Integra Lifesciences Corp.
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a...
Surgical Devices·95 affected·Jun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices·92 affected·Jun 29, 2018