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High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Medical Devices·0 affected·May 23, 2017
High RiskFDA
Elekta, Inc.
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target ...
Surgical Devices·2 affected·May 23, 2017
High RiskFDA
Shimadzu Medical Systems Usa Com
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Medical Devices·1,673 affected·May 23, 2017
High RiskFDA
Pentax Of America Inc
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit m...
Medical Devices·118 affected·May 23, 2017
High RiskFDA
Onkos Surgical, Inc.
ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, RE...
Medical Devices·4 affected·May 23, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Medical Devices·0 affected·May 23, 2017
High RiskFDA
Alaska Pasta Company
Ravioli Orso. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side ...
Food·120 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Fettuccine Gluten Free. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on ...
Food·10 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Papperdelli ¿ inch. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the ...
Food·108 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Lasagne Sheets. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side...
Food·13 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Lasagne Sheets Spinach. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on ...
Produce·19 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Linguine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of th...
Food·78 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Ravioli Butternut. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the s...
Dairy·24 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Shells. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the ...
Food·52 affected·May 22, 2017
High RiskFDA
Genetic Edge Compounds Llc
GEC TNT Thermanite 60 Capsules Dietary Supplement in clear plastic bottle, UPC: 689466706222.
Supplements·8,473 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Fettuccine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of...
Food·447 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Ravioli Cheese. Product is frozen. Product is packaged in plastic containers. The plastic containers are marked on the side of the con...
Dairy·68 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Penne. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the c...
Food·9 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Ravioli Lobster. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the si...
Seafood·37 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Ravioli Mushroom. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the s...
Food·38 affected·May 22, 2017
High RiskFDA
Alaska Pasta Company
Spaghettoni. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of...
Food·69 affected·May 22, 2017
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, K...
Oral Drugs·89,118 affected·May 22, 2017
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, K...
Oral Drugs·13,221 affected·May 22, 2017
High RiskFDA
Global Marketing Enterprises, Inc.
Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp...
Drugs·52 affected·May 22, 2017
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, K...
Oral Drugs·223,650 affected·May 22, 2017
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, K...
Oral Drugs·452,290 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical i...
Surgical Devices·453 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surg...
Surgical Devices·418 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.
Surgical Devices·30 affected·May 22, 2017
High RiskFDA
Creganna Medical Devices
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Medical Devices·100 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
Surgical Devices·2 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical inst...
Surgical Devices·3,640 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surg...
Surgical Devices·240 affected·May 22, 2017
High RiskFDA
Becton Dickinson & Co.
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for c...
Medical Devices·250 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical in...
Surgical Devices·1,091 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.
Surgical Devices·25 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instr...
Surgical Devices·1,286 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic sur...
Surgical Devices·4 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instr...
Surgical Devices·389 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. or...
Surgical Devices·10 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrum...
Surgical Devices·27 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
Surgical Devices·15 affected·May 22, 2017
High RiskFDA
Beckman Coulter Inc.
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting syst...
Diagnostic Devices·43 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.
Surgical Devices·2,240 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonster...
Surgical Devices·198 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
Surgical Devices·155 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgi...
Surgical Devices·25 affected·May 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic su...
Surgical Devices·198 affected·May 22, 2017