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High RiskFDA
Brainlab Ag
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Medical Devices·80 affected·Nov 16, 2017
High RiskFDA
Rich Products Corp
Brewhouse Macadamia Nut Cookie Dough Net Case Wt.: 26 LB 4 oz.. Frozen Net Unit Wt. 3 oz. Approximate Count:140 Product Code: 1380...
Bakery & Grains·24 affected·Nov 15, 2017
High RiskFDA
Meijer Distribution, Inc
Roasted & Salted Cashews and Chocolate Covered Cashews; packaged in clear plastic containers; NET WT 18 oz. (1 LB 2 oz.), 510 g; UPC 8-...
Snacks & Candy·48 affected·Nov 15, 2017
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-H...
Medical Implants·560 affected·Nov 15, 2017
High RiskFDA
Cordis Corporation
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the bili...
Medical Implants·511 affected·Nov 15, 2017
High RiskFDA
Medacta Usa Inc
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or re...
Medical Devices·837 affected·Nov 15, 2017
High RiskFDA
Ahold Usa
Ahold-Own Brands Whole Kernel Sweet Corn, 16 oz. Plastic Bag : Stop & Shop Brand Frozen Whole Kernel Sweet Corn, 16 oz. GIANT/MAR...
Frozen Food·3,793 affected·Nov 14, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
Medical Devices·18,124 affected·Nov 14, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrie...
Surgical Devices·18,124 affected·Nov 14, 2017
High RiskFDA
Carl Zeiss Metrology Inc
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Medical Devices·13 affected·Nov 14, 2017
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for u...
Surgical Devices·18,124 affected·Nov 14, 2017
High RiskFDA
Alere San Diego, Inc.
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solutio...
Diagnostic Devices·2,940 affected·Nov 14, 2017
High RiskFDA
Arise Gluten Free Bakery
Arise Gluten Free Bakery Wild Yeast Sourdough; NET WEIGHT 24 OZ (680 grams) UPC 095225600005
Food·73 affected·Nov 13, 2017
High RiskFDA
Arise Gluten Free Bakery
Arise Gluten Free Bakery Dark and Seedy Sourdough; NET WEIGHT 24 OZ (680 grams) UPC 0952256000067 Tony s item # 12485
Food·25 affected·Nov 13, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Injectable Drugs·25,356 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Amendia, Inc Dba Spinal Elements
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization...
Surgical Devices·82 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Bush Brothers & Co
BUSH'S BEST¿ Homestyle TANGY SAUCE WITH BACON & BROWN SUGAR BAKED BEANS 55 OZ (3 LB 7 OZ) 1.56 kg BUSH BROTHERS & COMPANY P.O. Box 52330...
Food·159 affected·Nov 11, 2017
High RiskFDA
Bush Brothers & Co
BUSH'S BEST¿ Original SEASONED WITH BACON & BROWN SUGAR BAKED BEANS 55 OZ (3 LB 7 OZ) 1.56 kg BUSH BROTHERS & COMPANY P.O. Box 52330, Dep...
Food·160 affected·Nov 11, 2017
High RiskFDA
New Century Snacks Llc
Raley's Purely Made Dry Roasted Unsalted Peanuts; 12 oz. (340 g) clear plastic bag. No artificial ingredients. Some packages may be l...
Food·221 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission dat...
Medical Devices·3 affected·Nov 10, 2017
High RiskFDA
C.r. Bard, Inc.
CritiCore Automated Urine Output and Temperature Monitor
Medical Devices·0 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at differen...
Medical Devices·13 affected·Nov 10, 2017
High RiskFDA
Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port ...
Medical Devices·756 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data ta...
Medical Devices·1 affected·Nov 10, 2017
High RiskFDA
Wiener Laboratories
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Medical Devices·1,563 affected·Nov 10, 2017
High RiskFDA
Nxstage Medical, Inc.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Medical Devices·1,243,400 affected·Nov 10, 2017
High RiskFDA
Zevex Incorporated (dba Moog Medical Medical Devices Group)
MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, p...
Medical Devices·2,497 affected·Nov 10, 2017
High RiskFDA
Ventura Foods Llc
SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g. Keep Refrigerated. UPC 26700-13499. Ou...
Dairy·9 affected·Nov 9, 2017
High RiskFDA
First Source, Llc
Organic Dark Chocolate (Covered) Cherries: Wegmans Organic Dark Chocolate Cherries NET WT 14 OZ (396g), UPC: 0 77890 37785 7, Product cod...
Snacks & Candy·751 affected·Nov 9, 2017
High RiskFDA
First Source, Llc
Organic Dark Chocolate (Covered) Raisins; Wegmans organic Dark Chocolate Covered Raisins NET WT 14 OZ (396g), UPC: 0 77890 37787 1, Produ...
Snacks & Candy·751 affected·Nov 9, 2017
High RiskFDA
Figi's, Inc
Dark Chocolate covered Gingersnaps. Packaged as follows: 1. in clear plastic ziplock bag, sizes range from 8 oz - 12 oz., product code ...
Snacks & Candy·20 affected·Nov 9, 2017
High RiskFDA
First Source, Llc
Wegmans Organic Dark Chocolate Covered Cranberries NET WT 14 OZ (396g) UPC: 0 77890 37786 4, Product code 5546289
Snacks & Candy·751 affected·Nov 9, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Ma...
Oral Drugs·3,870 affected·Nov 9, 2017
High RiskFDA
Mayne Pharma Inc
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
Oral Drugs·11,364 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
Medical Devices·732 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Medical Devices·320 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Medical Devices·12 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Medical Devices·900 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Medical Devices·51 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-...
Medical Devices·504 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 ...
Medical Devices·1,542 affected·Nov 9, 2017
High RiskFDA
Vascular Insights, Llc
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion ...
Surgical Devices·928 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurize...
Medical Devices·444 affected·Nov 9, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stim...
Diagnostic Devices·989 affected·Nov 9, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Medical Devices·384 affected·Nov 9, 2017