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High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Diagnostic Devices·10,310,443 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counte...
Cardiac Devices·12,744 affected·Feb 21, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic an...
Medical Devices·14 affected·Feb 21, 2018
High RiskFDA
Margalaxy Llc
Cosmic Crunch Granola, packaged in paper bag, net wt 10 oz. The product is labeled in parts: "***COSMIC CRUNCH superfood granola***1...
Bakery & Grains·20 affected·Feb 20, 2018
High RiskFDA
Hospira Inc. A Pfizer Company
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest,...
Injectable Drugs·137,975 affected·Feb 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PA...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chl...
Surgical Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a pack...
Diabetes Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report,...
Medical Devices·92 affected·Feb 20, 2018
High RiskFDA
Deerfield Imaging, Inc.
IMRIS T2X Table, Part Number 109682-600
Medical Devices·16 affected·Feb 20, 2018
High RiskFDA
Cardinal Health 200, Llc
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet...
Diabetes Devices·8,928 affected·Feb 20, 2018
High RiskFDA
Ventura Foods, Llc
Gordon Choice Asian Sesame Ginger Dressing, Net Contents/Contenido Neto 128 FL OZ; For Distribution Exclusively By Gordon Food Service Wy...
Food·144 affected·Feb 19, 2018
High RiskFDA
Kalchem International, Inc.
Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, ...
Drugs·500 affected·Feb 19, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki Cabbage, Net WT 14 oz. (396g), Keep Frozen, UPC: 7 07163 02619 8
Frozen Food·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki, Potato and Mushroom, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 07163 02617 4
Frozen Food·0 affected·Feb 16, 2018
High RiskFDA
Double-cola Co.-usa Dba The Double Cola Company
Cherry SKI LEMON ORANGE AUTHENTIC CITRUS SODA 12 oz can CONTAINS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, LEMON JUICE CONCENTRATE, OR...
Beverages·200 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki Potato and Onion, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0 7163 02616 7
Produce·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese, Net Wt. 14 oz. (396 g); UPC Codes: 7 07163 30325 1, Keep...
Dairy·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki Sour Cherry, Net Wt. 14oz (396g), Keep Frozen, UPC: 7 07163 02615 0
Frozen Food·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Hand Made Russian Style Blintzes, (6 pieces): Cheese and Cherry, Net Wt. 14 oz. (396g), UPC Codes: 7 07163 303...
Dairy·0 affected·Feb 16, 2018
High RiskFDA
M & P Food Productions, Ltd.
M&P Food Productions brand Vareniki - farmer cheese, Hand made, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 0716 302618 1
Dairy·0 affected·Feb 16, 2018
High RiskFDA
B. Braun Medical Inc
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catal...
Drugs·17,360 affected·Feb 16, 2018
High RiskFDA
Medline Industries Inc
PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industri...
Drugs·67,104 affected·Feb 15, 2018
High RiskFDA
Apollo Care
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71...
Injectable Drugs·360 affected·Feb 15, 2018
High RiskFDA
Apollo Care
Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC...
Injectable Drugs·312 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Transonic Systems Inc
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extrac...
Cardiac Devices·6,044 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Teleflex Medical
Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
Medical Devices·12 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Medical Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Cardiac Devices·1,301 affected·Feb 15, 2018
High RiskFDA
Ra Medical Systems Inc
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in t...
Surgical Devices·4 affected·Feb 15, 2018
High RiskFDA
Fagron, Inc
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, M...
Drugs·1,007 affected·Feb 14, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation...
Medical Devices·18 affected·Feb 14, 2018
High RiskFDA
Brainlab Ag
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a med...
Medical Devices·587 affected·Feb 14, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to d...
Medical Devices·18 affected·Feb 14, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray r...
Medical Devices·7 affected·Feb 14, 2018
High RiskFDA
Hetero Labs Limited Unit V
Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero ...
Oral Drugs·48,132 affected·Feb 13, 2018
High RiskFDA
Hetero Labs Limited Unit V
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: ...
Oral Drugs·1,764 affected·Feb 13, 2018
High RiskFDA
Nostrum Laboratories Inc
Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. ND...
Oral Drugs·1,439,000 affected·Feb 13, 2018
High RiskFDA
Pentax Of America Inc
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide ...
Medical Devices·559 affected·Feb 13, 2018
High RiskFDA
Becton Dickinson & Company
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
Medical Devices·9,568,900 affected·Feb 13, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
Diagnostic Devices·3,322 affected·Feb 13, 2018
High RiskFDA
Stanbio Laboratory, Lp
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156...
Diagnostic Devices·686 affected·Feb 13, 2018