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High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-s...
Medical Devices·448 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sens...
Medical Devices·331 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensi...
Medical Devices·37 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible...
Medical Devices·100 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensit...
Medical Devices·308 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible p...
Medical Devices·660 affected·Jun 21, 2013
High RiskFDA
Picis Inc.
Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a d...
Medical Devices·35 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-s...
Medical Devices·110 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polyme...
Medical Devices·45 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-...
Medical Devices·220 affected·Jun 21, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of pla...
Medical Devices·13 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-...
Medical Devices·100 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensi...
Medical Devices·652 affected·Jun 21, 2013
High RiskFDA
Genzyme Corporation, A Sanofi Company
LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible...
Medical Devices·181 affected·Jun 21, 2013
High RiskFDA
Beta Labs
PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802
Food·743 affected·Jun 20, 2013
High RiskFDA
Beta Labs
RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 197...
Food·743 affected·Jun 20, 2013
High RiskFDA
Gilead Sciences, Inc.
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas P...
Injectable Drugs·478,352 affected·Jun 20, 2013
High RiskFDA
Haemonetics Corporation
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Medical Devices·1,590 affected·Jun 20, 2013
High RiskFDA
Garden-fresh Foods, Inc.
LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99...
Seafood·126 affected·Jun 19, 2013
High RiskFDA
Astellas Pharma Us Inc
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astell...
Injectable Drugs·133,550 affected·Jun 19, 2013
High RiskFDA
Biosense Webster, Inc.
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Cardiac Devices·10 affected·Jun 19, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5...
Medical Implants·85 affected·Jun 19, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are inten...
Surgical Devices·99 affected·Jun 19, 2013
High RiskFDA
Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item code...
Medical Implants·85 affected·Jun 19, 2013
High RiskFDA
Carestream Health Inc.
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The...
Medical Devices·331 affected·Jun 19, 2013
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6...
Cardiac Devices·66,150 affected·Jun 19, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating...
Surgical Devices·4 affected·Jun 19, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, ...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and ph...
Drugs·917,400 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride...
Drugs·292,320 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berr...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powde...
Drugs·1,871,122 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder ...
Drugs·1,202,960 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-cou...
Drugs·1,140,564 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder pack...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Oral Drugs·7,579 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powd...
Drugs·868,104 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Oral Drugs·16,293 affected·Jun 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Oral Drugs·13,478 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Sou...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per...
Drugs·398,208 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) pow...
Drugs·3,753,348 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, le...
Drugs·0 affected·Jun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural A...
Drugs·1,614,564 affected·Jun 18, 2013
High RiskFDA
Invacare Corporation
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in pers...
Medical Devices·285 affected·Jun 18, 2013
High RiskFDA
Hospira Inc.
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NO...
Medical Devices·14,400 affected·Jun 18, 2013