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High RiskFDA
Oxford Frozen Foods Plant 1
ALE HOUSE BEER BATTERED 3/8 ONION RINGS - NET WT. 4/2.5 lb (1.13 kg) 10 lb (4.54 kg) - 33221
Produce·36,983 affected·Jun 7, 2017
High RiskFDA
Sea Watch International Ltd
Sailors Choice Brand Breaded Clam Strips Pack Size: 24/4 oz. bags/case
Bakery & Grains·1,705 affected·Jun 7, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Almond Yogurt, Blueberry , NET WT. 5.3 oz (150G) Case UPC: 8-56624-00413-5 Distributed by Lyrical Foods, Hayward, CA.
Dairy·1,606 affected·Jun 7, 2017
High RiskFDA
Slade Gorton & Company, Inc.
Gourmet Bay - Honey Mustard Breaded Tilapia, 5-7 oz.. refrigerated (Bulk 5 lbs container) Product Code: 7324801
Bakery & Grains·19,773 affected·Jun 7, 2017
High RiskFDA
Sea Watch International Ltd
Sea Watch Beer Battered Clam Strips Pack Size: 2/3 lb. bags/case
Food·1,154 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to pro...
Medical Devices·64 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended ...
Medical Devices·145 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Mako Surgical Corporation
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial bou...
Medical Devices·20 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-se...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1...
Surgical Devices·214 affected·Jun 7, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Medical Devices·5,992 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cr...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty proc...
Surgical Devices·426 affected·Jun 7, 2017
High RiskFDA
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Medical Devices·0 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-s...
Medical Devices·1,890 affected·Jun 7, 2017
High RiskFDA
Greencore Usa
Ham Salad Sandwich under the following labels: Enza's Choice Ham Salad on Wheat Bread, 6.6 oz. UPC 73508758165. Hannaford Ham Salad ...
Meat & Poultry·17,123 affected·Jun 6, 2017
High RiskFDA
Greencore Usa
Hannaford Classic Seafood stuffing, 10 oz. UPC 41268205097
Seafood·1,065 affected·Jun 6, 2017
High RiskFDA
Greencore Usa
Tuna Salad Sandwich under the following labels: Enzas Choice Tuna Salad on Wheat Bread, 6.6 0z UPC 73508757486 Hannaford Tuna Salad on...
Seafood·8,542 affected·Jun 6, 2017
High RiskFDA
Bausch & Lomb, Inc.
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distrib...
Inhaled / Nasal Drugs·44,520 affected·Jun 6, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7...
Medical Devices·0 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets ea...
Medical Devices·8 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Medical Devices·1 affected·Jun 6, 2017
High RiskFDA
Microbiologics Inc
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are ...
Respiratory Devices·1 affected·Jun 6, 2017
High RiskFDA
Apothecary By Design
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Str...
Injectable Drugs·25 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Prod...
Medical Implants·6,290 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 ...
Medical Implants·1,517 affected·Jun 5, 2017
High RiskFDA
Angiodynamics, Inc.
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with...
Medical Devices·14,353 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide ...
Medical Implants·7,888 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
Lateral Troch Plate Full Crimp - 254mm, model # 350838
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Medical Devices·0 affected·Jun 5, 2017
High RiskFDA
Angiodynamics, Inc.
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Su...
Medical Devices·14,353 affected·Jun 5, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manu...
Medical Devices·17,280 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Ti...
Medical Implants·10,116 affected·Jun 5, 2017
High RiskFDA
Angiodynamics, Inc.
Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a ...
Medical Devices·14,353 affected·Jun 5, 2017
High RiskFDA
Zimmer Biomet, Inc.
OSS CEMENTED IM STEM 12X150, model # 150366
Medical Devices·0 affected·Jun 5, 2017