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High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiop...
Respiratory Devices·27 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulm...
Respiratory Devices·8 affected·Jul 27, 2017
High RiskFDA
Baxter Healthcare Corporation
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug...
Medical Devices·29,088 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomo...
Medical Devices·326 affected·Jul 27, 2017
High RiskFDA
Natureall-stf Holding, Llc
Leci-thin-Plus, No. 88, 90 Capsules, Dietary Supplement
Supplements·80 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Heart-Plus, No. 83, 120 Capsules, Dietary Supplement
Supplements·598 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Pancreas-Plus, No. 112, 90 Capsules, Dietary Supplement
Supplements·566 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Liver-Plus, No. 111 & 115, 120 Capsules, Dietary Supplement
Supplements·400 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Prostate-Plus, No. 117, 90 Capsules, Dietary Supplement
Supplements·186 affected·Jul 26, 2017
High RiskFDA
Hospira Inc, Lake Forest
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., I...
Injectable Drugs·14,300 affected·Jul 26, 2017
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-798...
Injectable Drugs·436,716 affected·Jul 26, 2017
High RiskFDA
Hospira Inc, Lake Forest
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc....
Injectable Drugs·9,009 affected·Jul 26, 2017
High RiskFDA
Hospira Inc, Lake Forest
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 v...
Injectable Drugs·56,340 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·6,257 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic ...
Medical Devices·6 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar sp...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·1,144 affected·Jul 26, 2017
High RiskFDA
Gold Medal Products Co
CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufactured by GOLD MEDAL PRODUCTS CO.
Food·806 affected·Jul 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, r...
Medical Devices·36 affected·Jul 25, 2017
High RiskFDA
Arrow International Inc
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Surgical Devices·2,691 affected·Jul 25, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-572...
Oral Drugs·28,188 affected·Jul 24, 2017
High RiskFDA
Epimed International
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, Fo...
Surgical Devices·500 affected·Jul 24, 2017
High RiskFDA
Epimed International
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Medical Devices·263 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
3-Way Standardbore Stopcock. Product Code: AMS-100.
Medical Devices·200 affected·Jul 24, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricu...
Medical Implants·72 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
Medical Devices·156 affected·Jul 24, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricul...
Medical Implants·68 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
Medical Devices·300 affected·Jul 24, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only ...
Medical Implants·402 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
Medical Devices·0 affected·Jul 24, 2017
High RiskFDA
Sorin Group Italia Srl - Crf
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricu...
Medical Implants·86 affected·Jul 24, 2017
High RiskFDA
Zimmer Orthopedic Mfg Ltd
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Medical Devices·7 affected·Jul 24, 2017
High RiskFDA
D & D Foods, Inc.
Hy-Vee, Cheese Pizza, 16'' Thin Crust, UPC 288942 611991, Net Wt. 29 oz (1 lb 13 oz) 1.81 lb (822 g), West Des Moines, IA
Dairy·119 affected·Jul 22, 2017
High RiskFDA
D & D Foods, Inc.
Hy-Vee, Cheese Pizza, 12'' Thin Crust, UPC 288914 908999, Net Wt. 17 oz (1 lb 1 oz) 1.06 lb (482 g), West Des Moines, IA
Dairy·182 affected·Jul 22, 2017
High RiskFDA
D & D Foods, Inc.
Hy-Vee, Cheese Pizza, 12'' Traditional Crust, UPC 288900 908996, Net Wt. 26 oz (1 lb 10 oz) 1.62 lb (737 g), West Des Moines, IA
Dairy·471 affected·Jul 22, 2017
High RiskFDA
Qiagen, Gmbh
QIAamp DSP Virus Kit Cat. No. 60704
Medical Devices·555 affected·Jul 22, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Cow Trax Ice Cream 1 pint
Dairy·6 affected·Jul 21, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Salted Caramel Ice Cream 1 pint
Dairy·45 affected·Jul 21, 2017
High RiskFDA
Bush Brothers & Co
BUSHS BEST¿ Country Style THICK, RICH SAUCE WITH BACON & EXTRA BROWN SUGAR 28 OZ (1 LB 12 OZ) 794 g BUSH BROTHERS & COMPANY P. O. Box 523...
Food·5,979 affected·Jul 21, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Intense Dark Chocolate Ice Cream 1 pint
Dairy·12 affected·Jul 21, 2017
High RiskFDA
Professional Complementary Health Formulas, Llc
Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles. Adhesive lab...
Baby Food & Formula·2,178 affected·Jul 21, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Banana Pudding Y'all Ice Cream 1 pint
Dairy·53 affected·Jul 21, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Chocolate Squared Ice Cream 1 pint
Dairy·420 affected·Jul 21, 2017
High RiskFDA
Duy Drugs Inc.
Cardiovid Plus, Cardiovascular Active Dietary Supplement, 60 Softgels
Supplements·411 affected·Jul 21, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Strawberry Fields Forever Ice Cream 1 pint
Dairy·453 affected·Jul 21, 2017
High RiskFDA
Koogee-queen Anne, Llc
The Comfy Cow Cookies & Cream Ice Cream 1 pint
Dairy·134 affected·Jul 21, 2017
High RiskFDA
Bush Brothers & Co
BUSHS BEST¿ Original SEASONED WITH BACON & BROWN SUGAR BAKED BEANS 28 OZ (1 LB 12 OZ) 794 g BUSH BROTHERS & COMPANY P. O. Box 52330, Dept...
Food·16,887 affected·Jul 21, 2017