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High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the ...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Ricos Tostaditos, Inc.
RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Hot Crispy and Delicious Net Wt. 3/4 oz. (21g)
Food·150 affected·Nov 19, 2014
High RiskFDA
Ricos Tostaditos, Inc.
RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Crispy and Delicious Net Wt. 3/4 oz. (21g)
Food·300 affected·Nov 19, 2014
High RiskFDA
Ricos Tostaditos, Inc.
RICOS Tostaditos Chiviricos Fried Dough Crispy and Delicious Net Wt. 2-1/4 oz. (64g)
Food·4,000 affected·Nov 19, 2014
High RiskFDA
American Health Packaging
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories I...
Oral Drugs·3,496 affected·Nov 19, 2014
High RiskFDA
Brainlab Ag
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radi...
Medical Devices·1,412 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Prod...
Cardiac Devices·74,499 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for...
Cardiac Devices·27,918 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitativ...
Diagnostic Devices·658 affected·Nov 19, 2014
High RiskFDA
Natus Medical Incorporated
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Medical Devices·1,907 affected·Nov 19, 2014
High RiskFDA
Kci Usa, Inc.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H2...
Medical Devices·1,139 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Cardiac Devices·1,553 affected·Nov 19, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator sy...
Medical Devices·3 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VIT...
Diagnostic Devices·339 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneo...
Medical Devices·86 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-...
Diagnostic Devices·1,830 affected·Nov 19, 2014
High RiskFDA
Cheesecake Royale, Inc.
Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. D...
Dairy·70 affected·Nov 17, 2014
High RiskFDA
Cheesecake Royale, Inc.
Turtle Fudge Brownies, Net Wt. (5 lbs), Item # 042, UPC#85538300042
Food·31 affected·Nov 17, 2014
High RiskFDA
Cheesecake Royale, Inc.
Rocky Road Brownies, Net Wt. (5 lbs), Item # 041, UPC#85538300041
Food·256 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ma...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, MIXTER FORCEPS, P/N 0250080249. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of ti...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Laparoscopic Manual Instruments are intended for cutting, holdin...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ma...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 3.5MM TROCAR, PYRAMIDAL TIP, SHORT, P/N 0250080692 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulatin...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and man...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and man...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and mani...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulati...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, MIXTER FORCEPS, P/N 0250080010. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of ti...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipula...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM SHAFT, NEEDLE HOLDER CURVED LEFT 45CM, P/N 0250080589 Laparoscopic Manual Instruments are intended for cutting, holding, graspi...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 Laparoscopic Manual Instruments are intended for cutting, ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Ca...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM INSERT BIOPSY FORCEPS, SPOON W/PIN, 45CM, P/N 0250080581 Laparoscopic Manual Instruments are intended for cutting, holding, gra...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and mani...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of ti...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006 Laparoscopic Manual Instruments are intended for cutting, holding, g...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080071. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and mani...
Surgical Devices·180,573 affected·Nov 17, 2014