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High RiskFDA
Ormco/sybronendo
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires ...
Medical Devices·8,210 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or ...
Surgical Devices·53,151 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the ...
Medical Devices·2 affected·Mar 8, 2013
High RiskFDA
Linde Gas North America Llc
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adult...
Respiratory Devices·52,264 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partu...
Surgical Devices·8,216 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the fo...
Medical Devices·62 affected·Mar 8, 2013
High RiskFDA
Ozone Confection & Bakers Supply Co.
Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Food·481 affected·Mar 7, 2013
High RiskFDA
Chu Minh Corp
CHU MINH TOFU Fried Soybean Cake (Tofu), net weight 12 oz. The UPC is 8 18140 00003 9. The product is labeled in parts: "***CHUMINH T...
Bakery & Grains·0 affected·Mar 7, 2013
High RiskFDA
Ozone Confection & Bakers Supply Co.
Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Food·481 affected·Mar 7, 2013
High RiskFDA
Ozone Confection & Bakers Supply Co.
Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Food·481 affected·Mar 7, 2013
High RiskFDA
Chu Minh Corp
CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. The product is labeled in parts: "***CHUMINH T...
Bakery & Grains·0 affected·Mar 7, 2013
High RiskFDA
Sanofi Us
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC ...
Oral Drugs·2,462 affected·Mar 7, 2013
High RiskFDA
Maquet Cardiovascular, Llc
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxyg...
Respiratory Devices·154 affected·Mar 7, 2013
High RiskFDA
Devilbiss Healthcare Llc
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6...
Respiratory Devices·112,849 affected·Mar 7, 2013
High RiskFDA
Shantea Llc
ShanTea Ride The Dragon Honeybush/Licorice (UPC 794504283808) USDA Organic.
Beverages·97 affected·Mar 6, 2013
High RiskFDA
Shantea Llc
ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic.
Beverages·111 affected·Mar 6, 2013
High RiskFDA
Smith & Nephew Inc
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orth...
Medical Devices·23 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determine...
Medical Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Advanced Orthogonal Equipment, Incorporated
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adj...
Medical Devices·54 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively meas...
Diabetes Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (AL...
Medical Devices·38,571 affected·Mar 6, 2013
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, Ind...
Oral Drugs·13,320 affected·Mar 5, 2013
High RiskFDA
Stryker Endoscopy
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical site...
Surgical Devices·1,965 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Stryker Endoscopy
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera t...
Surgical Devices·1,965 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Biosense Webster, Inc.
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the...
Surgical Devices·54 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0...
Drugs·8,960,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged ...
Drugs·46,500 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170...
Drugs·698,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per...
Drugs·544,500 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-coun...
Drugs·3,032,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit...
Drugs·929,000 affected·Mar 4, 2013
High RiskFDA
Arrow International Inc
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Ang...
Cardiac Devices·99,627 affected·Mar 4, 2013
High RiskFDA
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system....
Medical Devices·23 affected·Mar 4, 2013
High RiskFDA
Steris Corporation
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683...
Medical Devices·1,677 affected·Mar 4, 2013
High RiskFDA
Bay Valley Foods Llc/ Treehouse Foods, Inc
55613130643 Our Specialty Linguini & Parmesan, Linguini pasta with naturally flavored Parmesan & Romano Cheese Sauce Mix, Net WT 5.8 ...
Dairy·390,096 affected·Mar 1, 2013
High RiskFDA
Beehive Botanicals, Inc.
Propolis Powder -100% Standardized Bee-Propolis Lot #: 021113-55/60, EXP: 10/14 11# Bag & Lot#: 10081155/60-120612-100, EXP: 12/15, 1# BAG.
Food·4,615 affected·Mar 1, 2013
High RiskFDA
Bay Valley Foods Llc/ Treehouse Foods, Inc
55613210946 Western Family, Easy Sides, Herb & Butter Pene, Net WT 5.5 oz (156 g), UPC "0 15400 12655 7", Proudly Distributed by Weste...
Dairy·1,102 affected·Mar 1, 2013
High RiskFDA
Bay Valley Foods Llc/ Treehouse Foods, Inc
556132100582 Meijer, Angel Hair Pasta with Herbs Angel Hair Pasta with Creamy Herb Sauce Mix , Net WT 4.8 oz ( 136g), UPC 7 19283 736...
Food·2,867 affected·Mar 1, 2013
High RiskFDA
Bay Valley Foods Llc/ Treehouse Foods, Inc
55613205218 Pasta on the Side,  Angel Hair Pasta with Herbs, Net WT 4.8 oz ( 136g), UPC 0 51933 08275 5, Distributed by Save- A- Lot ...
Food·35,028 affected·Mar 1, 2013
High RiskFDA
Bumble Bee International
Bumble Bee Brand 5oz Chunk Light Tuna in Vegetable Oil
Seafood·9,940 affected·Mar 1, 2013
High RiskFDA
Bumble Bee International
Brunswick and Bumble Bee Brand 5oz Chunk Light Tuna in Water.
Seafood·37,482 affected·Mar 1, 2013
High RiskFDA
Bumble Bee International
Bumble Bee Brand 5oz Chunk White Albacore in Water
Beverages·6,692 affected·Mar 1, 2013