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High RiskFDA
Biomet, Inc.
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180...
Medical Implants·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, ...
Medical Devices·0 affected·Nov 25, 2020
High RiskFDA
George Delallo Co. Inc. New Stanton Warehouse And Production
Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8
Food·166 affected·Nov 24, 2020
High RiskFDA
Ascend Laboratories Llc
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distribute...
Oral Drugs·1,200 affected·Nov 24, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Medical Devices·3,044 affected·Nov 24, 2020
High RiskFDA
Shenandoah Growers, Inc.
Organic fresh cut basil packaged in plastic clamshell containers The Fresh Market Organic Basil NET WT 0.5oz (14g), UPC:7-37094-23027-...
Food·1,660 affected·Nov 23, 2020
High RiskFDA
Ascend Laboratories Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed)...
Oral Drugs·20,232 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·2,246 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·123 affected·Nov 23, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Cardiac Devices·2 affected·Nov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices·85 affected·Nov 23, 2020
High RiskFDA
Covidien Llc
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and ...
Surgical Devices·5,316 affected·Nov 23, 2020
High RiskFDA
Ge Healthcare, Llc
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography ...
Cardiac Devices·3 affected·Nov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma...
Diagnostic Devices·731 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·912 affected·Nov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-gl...
Diagnostic Devices·397 affected·Nov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices·248 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administ...
Medical Devices·9,353 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·278 affected·Nov 23, 2020
High RiskFDA
Roche Molecular Systems, Inc.
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Medical Devices·27 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administ...
Medical Devices·140,006 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·224 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of...
Medical Devices·112,463 affected·Nov 23, 2020
High RiskFDA
Covidien Llc
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thora...
Surgical Devices·3,255 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·3,083 affected·Nov 23, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Medical Devices·152 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies ...
Medical Devices·2 affected·Nov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices·16 affected·Nov 23, 2020
High RiskFDA
Riverside Natural Foods, Ltd.
Good & Gather Banana Chocolate Chip Date & Nut Bars, UPC 0 85239-04216 8. 5-1.6 oz (45g) Bars. Net Wt. 8oz (225g). DIST BY: Target Co...
Snacks & Candy·508 affected·Nov 20, 2020
High RiskFDA
Out Of The Kitchen, Llc
Chef Mitch Maier's Black Garlic Ketchup. Net Wt. 19 oz. (538g). UPC 8 60248-00254 5.
Food·768 affected·Nov 20, 2020
High RiskFDA
J F C International Inc
YAGUMO AMANATTO GIFT BOX 6P 6/19.01 OZ JAN Code: 49 03089 39050 4 Imported by JFC International Inc. Los Angeles, CA 90040
Food·1,050 affected·Nov 20, 2020
High RiskFDA
Out Of The Kitchen, Llc
Chef Mitch Maier's Black Garlic Sauce. Net Wt. 16 oz. (473g). UPC 8 60248-00253 8.
Food·768 affected·Nov 20, 2020
High RiskFDA
Out Of The Kitchen, Llc
Chef Mitch Maier's Black Garlic BBQ Sauce. Net Wt. 19 oz. (538g). UPC 8 60248-00251 4.
Food·768 affected·Nov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unprese...
Injectable Drugs·2,400 affected·Nov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpres...
Injectable Drugs·1,182 affected·Nov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unprese...
Injectable Drugs·2,418 affected·Nov 20, 2020
High RiskFDA
Complete Pharmacy And Medical Solutions, Llc.
HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unprese...
Injectable Drugs·1,144 affected·Nov 20, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitat...
Diagnostic Devices·40 affected·Nov 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices ...
Cardiac Devices·58,438 affected·Nov 20, 2020
High RiskFDA
Zimmer Biomet, Inc.
Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument i...
Medical Devices·4,713 affected·Nov 20, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analyti...
Medical Devices·40 affected·Nov 20, 2020
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are u...
Cardiac Devices·0 affected·Nov 20, 2020
High RiskFDA
Haag-streit Usa Inc
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes ...
Surgical Devices·3 affected·Nov 20, 2020
High RiskFDA
Us Pharmaceuticals Inc.
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, R...
Topical Drugs·3,312 affected·Nov 19, 2020
High RiskFDA
Areva Pharmaceuticals Inc
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, In...
Injectable Drugs·3,287 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Surgical Devices·1,566 affected·Nov 19, 2020
High RiskFDA
Steris Corporation
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during...
Medical Devices·23,445 affected·Nov 19, 2020
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
Surgical Devices·1,231 affected·Nov 19, 2020