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High RiskFDA
Bd Biosciences, Systems & Reagents
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Diagnostic Devices·35 affected·Jun 6, 2014
High RiskFDA
U-can Food Trading Inc
The Cookies Cottage (Brand) Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits), 180g. Packaged in 24packets per carton.
Bakery & Grains·82 affected·Jun 5, 2014
High RiskFDA
Parkers Farm Inc
Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid.
Food·1,264 affected·Jun 5, 2014
High RiskFDA
Parkers Farm Inc
Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on...
Food·1,264 affected·Jun 5, 2014
High RiskFDA
Parkers Farm Inc
Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid.
Food·1,264 affected·Jun 5, 2014
High RiskFDA
Parkers Farm Inc
Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17...
Dairy·1,264 affected·Jun 5, 2014
High RiskFDA
Parkers Farm Inc
Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail with snap on lid ...
Dairy·1,264 affected·Jun 5, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jer...
Oral Drugs·3,881 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee and Artis zeego systems. x-ray, angiographic system
Medical Devices·206 affected·Jun 5, 2014
High RiskFDA
Argon Medical Devices, Inc
UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (3...
Surgical Devices·3,783 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Argon Medical Devices, Inc
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) ...
Surgical Devices·3,783 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
Teleflex Medical
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Respiratory Devices·7,758,650 affected·Jun 5, 2014
High RiskFDA
National Vitamin Co Inc
Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5
Food·13,240 affected·Jun 4, 2014
High RiskFDA
Pall Corporation
PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. ...
Medical Devices·24,650 affected·Jun 4, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated fo...
Diagnostic Devices·1,053 affected·Jun 4, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all ...
Diagnostic Devices·3,460 affected·Jun 4, 2014
High RiskFDA
Blue Belt Technologies Mn
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
Medical Implants·2 affected·Jun 4, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inv...
Respiratory Devices·7,371 affected·Jun 4, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrum...
Surgical Devices·29 affected·Jun 4, 2014
High RiskFDA
Deroyal Industries Inc
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries,...
Medical Devices·128 affected·Jun 4, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 500 CTS, automated coagulation laboratory instrument.
Medical Devices·2,802 affected·Jun 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgica...
Surgical Devices·10,467 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP (Base), automated coagulation laboratory instrument.
Medical Devices·1,074 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700, automated coagulation laboratory instrument.
Medical Devices·633 affected·Jun 3, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilato...
Respiratory Devices·104 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700 LAS, automated coagulation laboratory instrument.
Medical Devices·99 affected·Jun 3, 2014
High RiskFDA
Instrumentation Laboratory Co.
ACL TOP 700 CTS, automated coagulation laboratory instrument.
Medical Devices·266 affected·Jun 3, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf...
Surgical Devices·814 affected·Jun 3, 2014
High RiskFDA
Alcon Research, Ltd.
eye-pak 7407 Tray Support Cover REF 8065740745
Medical Devices·2,462 affected·Jun 3, 2014
High RiskFDA
Nihon Kohden America Inc
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple pat...
Cardiac Devices·430 affected·Jun 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solution...
Medical Devices·790 affected·Jun 3, 2014
High RiskFDA
Maui Soda & Ice Works Ltd/dba Roselani Ice Cream
Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI
Dairy·2,045 affected·Jun 2, 2014
High RiskFDA
Ebro North America Dba New World Pasta
Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-stable packed in blue paperboard box all codes
Food·90,011 affected·Jun 2, 2014
High RiskFDA
Frito-lay, Inc
Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189
Food·1,757,772 affected·Jun 2, 2014
High RiskFDA
Unit Dose Solutions Inc
Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Oral Drugs·1,177 affected·Jun 2, 2014
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Medical Devices·907 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc...
Diagnostic Devices·40 affected·Jun 2, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Num...
Diagnostic Devices·3,839 affected·Jun 2, 2014