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High RiskFDA
Covidien Llc
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and ba...
Surgical Devices·17,271 affected·Sep 21, 2017
High RiskFDA
Deserving Health International Corp
Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337....
Drugs·623 affected·Sep 20, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Medical Devices·643 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
Medical Devices·953 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Medical Devices·920 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
Medical Devices·306 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Medical Devices·665 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
Medical Devices·895 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
Medical Devices·311 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Medical Devices·333 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
Medical Devices·411 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
Medical Devices·575 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
Medical Devices·656 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
Medical Devices·520 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
Medical Devices·547 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
Medical Devices·678 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Medical Devices·640 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Medical Devices·733 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Medical Devices·527 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Medical Devices·198 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
Medical Devices·386 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
Medical Devices·573 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Medical Devices·109 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Medical Devices·114 affected·Sep 19, 2017
High RiskFDA
Grand Supercenter Inc.
HAIOREUM, RICE POP SNACK, KOREAN STYLE SNACK 0.41 LBS (190 G)
Snacks & Candy·1,580 affected·Sep 18, 2017
High RiskFDA
J R Simplot Co Corporate Hq
Simplot Traditional Tater Gem. Net Wt. 30 lb. (13.6 kg), foodservice corrugated case, 6/5 lbs. clear poly bags per case. UPC = 100 71...
Food·4,718 affected·Sep 18, 2017
High RiskFDA
Death Wish Coffee Company, Llc
Death Wish Nitro Canned Cold Brew Coffee 11 oz UPC: 851552005599
Beverages·80,777 affected·Sep 18, 2017
High RiskFDA
Grand Supercenter Inc.
HAIOREUM, RICE PANCAKE, KOREAN STYLE SNACK 5.29 OZ (150 G), Pumpkin
Bakery & Grains·100 affected·Sep 18, 2017
High RiskFDA
Grand Supercenter Inc.
HAIOREUM, RICE PANCAKE, KOREAN STYLE SNACK 5.29 OZ (150 G), Matcha (Green Tea)
Bakery & Grains·320 affected·Sep 18, 2017
High RiskFDA
Grand Supercenter Inc.
HAIOREUM, RICE PANCAKE, KOREAN STYLE SNACK 5.29 OZ (150 G), Sweet Potato
Bakery & Grains·17 affected·Sep 18, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 36504...
Diagnostic Devices·1,976,000 affected·Sep 18, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Sy...
Medical Devices·16 affected·Sep 18, 2017
High RiskFDA
Microport Orthopedics Inc.
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated f...
Medical Devices·48 affected·Sep 18, 2017
High RiskFDA
Pro Bioteks Laboratories
Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules. UPC 0-26341-12900-2
Supplements·600,000 affected·Sep 15, 2017
High RiskFDA
Kind Llc
KIND Dark Chocolate Nuts and Sea Salt Bar-containing 12 /1.4 oz (40 g) bars Box :16.08 oz (480 g) per pack. Box UPC: 02652 17751
Snacks & Candy·5,273 affected·Sep 15, 2017
High RiskFDA
Dr. Pepper Snapple Group Inc
Diet Rite, Pure Zero Cola, 0 calories, 0 caffeine, 0 sodium, Bottled under the authority of Dr. Pepper/Seven up Inc. Plano TX. packed in ...
Food·2 affected·Sep 15, 2017
High RiskFDA
Becton Dickinson & Company
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Pa...
Drugs·628,000 affected·Sep 15, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from...
Medical Devices·46 affected·Sep 15, 2017
High RiskFDA
Hill-rom Manufacturing, Inc.
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability...
Medical Devices·60 affected·Sep 15, 2017
High RiskFDA
Zimmer Biomet, Inc.
36MM COCR MODULAR HD -6MM
Medical Devices·23 affected·Sep 15, 2017
High RiskFDA
Hologic, Inc
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Diagnostic Devices·1 affected·Sep 15, 2017
High RiskFDA
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured ...
Medical Devices·48 affected·Sep 15, 2017
High RiskFDA
Shawnee Milling Company, Inc.
Shawnee Mills Peppered Gravy Mix, 2.75 oz and 24 oz.
Food·3,112 affected·Sep 14, 2017
High RiskFDA
Country Harvest, Inc.
Country Harvest brand Lentil Barley Soup, dried soup mix is packaged in poly pro bag, heat sealed and placed in another poly pro bag & ta...
Dairy·1,700 affected·Sep 14, 2017
High RiskFDA
Country Harvest, Inc.
Country Harvest brand Black Thunder Bean Soup, dried soup mix is packaged in poly pro bag, heat sealed and placed in another poly pro bag...
Dairy·30 affected·Sep 14, 2017
High RiskFDA
Medisca, Inc.
Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar ...
Drugs·34,600 affected·Sep 14, 2017