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High RiskFDA
Arrow International Inc
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material A...
Surgical Devices·50 affected·Jun 2, 2016
High RiskFDA
Dean Foods, Inc.
Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Gallon (3.78L) in plastic one gallon container; Fresh Meadow Gold Dairy Pure Heavy ...
Dairy·590 affected·Jun 1, 2016
High RiskFDA
Dean Foods, Inc.
Old Style Meadow Gold Heavy Whipping Cream Grade A Pint (473 mL) in waxed cardboard container
Dairy·60 affected·Jun 1, 2016
High RiskFDA
Dean Foods, Inc.
Meadow Gold Dairy Pure Fresh Half & Half One Quart (946 mL)
Dairy·1,206 affected·Jun 1, 2016
High RiskFDA
Aidarex Pharmaceuticals Llc
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Pack...
Oral Drugs·292 affected·Jun 1, 2016
High RiskFDA
Bbi Solutions Oem Ltd
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin ...
Diagnostic Devices·420 affected·Jun 1, 2016
High RiskFDA
Synthes (usa) Products Llc
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904...
Medical Implants·383 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synt...
Medical Implants·36 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe...
Medical Implants·19 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Produ...
Medical Implants·79 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usag...
Medical Implants·18 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synt...
Medical Implants·18 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Pro...
Medical Implants·75 affected·May 31, 2016
High RiskFDA
Pentax Of America Inc
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic...
Medical Implants·113 affected·May 31, 2016
High RiskFDA
Haitai Cheongju Factory
Matdongsan Peanuts Crunch Snack, Net Wt. 80g, 325g
Snacks & Candy·3,155 affected·May 27, 2016
High RiskFDA
Sid Wainer And Son
Domaine de Provence Neutral 3"¿ Cone Tart Shells Produced Exclusively for Sid Wainer & Son, New Bedford, MA UPC Code: 708152316856 ...
Produce·166 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Medical Devices·72 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Medical Devices·94 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Medical Devices·5 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Medical Devices·18 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Medical Devices·19 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Medical Devices·17 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Medical Devices·25 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Medical Devices·9 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Medical Devices·79 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Medical Devices·60 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Medical Devices·27 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Medical Devices·11 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Medical Devices·11 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Medical Devices·43 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Medical Devices·10 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Medical Devices·40 affected·May 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Medical Devices·7 affected·May 27, 2016
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that int...
Medical Implants·262 affected·May 26, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicate...
Medical Devices·8 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rhe...
Medical Devices·10 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. R...
Medical Devices·33 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. R...
Medical Devices·12 affected·May 26, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ...
Diagnostic Devices·53,897 affected·May 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. ...
Medical Devices·3 affected·May 26, 2016
High RiskFDA
Magic Seasoning Blends, Llc
OUTBACK STEAKHOUSE OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL 33609
Food·18,720 affected·May 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
TASTE BUDS SEASONED FLOUR, ITEM# ZEAON1040, NET WT. 40 LBS.
Food·5,120 affected·May 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
OUTBACK STEAKHOUSE COMPLETE BREADING MIX, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
Bakery & Grains·3,322 affected·May 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
WOW 101 TENDER BATTER, NET WT. 25 lbs, ITEM #: WOW101TNBT025
Food·325 affected·May 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMONS, TAMPA, FL 33609
Bakery & Grains·9,900 affected·May 25, 2016
High RiskFDA
Lactalis American Group, Inc.
PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactali...
Dairy·17,856 affected·May 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
OUTBACK STEAKHOUSE CRAWFISH/CHICKEN/CALAMARI BREADER, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
Meat & Poultry·3,320 affected·May 25, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·60 affected·May 25, 2016