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High RiskFDA
Hostess Brands, Llc
Hostess Donettes Glazed Mini Donuts, packaged in 9-17-ct and 6-17-ct bags of mini donuts, net wt. 10.50oz, UPC 888109110659;the most resp...
Food·505,704 affected·Jun 3, 2016
High RiskFDA
Hostess Brands, Llc
Crunch Mini Donuts, packaged in 6-14-ct and 9-14-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 9.5oz, UPC 888109...
Food·761,335 affected·Jun 3, 2016
High RiskFDA
Hostess Brands, Llc
Iced Raspberry cake with creamy filling, packaged as Hostess Zingers Raspberry in 10-ct multi-packs of individual cakes, net wt. 13.40oz ...
Bakery & Grains·553,056 affected·Jun 3, 2016
High RiskFDA
Hostess Brands, Llc
Hostess Donettes Double Chocolate Mini Donuts, packaged in 9-ct bags of mini donuts, net wt. 11.25 oz, UPC 888109150037, the most respons...
Snacks & Candy·95,769 affected·Jun 3, 2016
High RiskFDA
Riba Foods Inc
Bayou Brothers Creole Sauce NET WT 33OZ. (2 LBS 1 OZ) 936g packaged in a glass jar
Food·4,048 affected·Jun 3, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022,...
Medical Devices·1,864 affected·Jun 3, 2016
High RiskFDA
Arrow International Inc
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-ter...
Surgical Devices·1 affected·Jun 2, 2016
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
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