Becton Dickinson & Co. - BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station - Class 3 Recall
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2018 Category: Medical Devices Source Type: alerts
Biocare Medical, LLC - URO3 Triple Stain (CD44 p52 CK20) - Class 2 Recall
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical interpretation of any staining o...
Source: Medical Device Recalls - September 20, 2018 Category: Medical Devices Source Type: alerts
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc - PATHFAST MyoII - Class 2 Recall
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2018 Category: Medical Devices Source Type: alerts
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc - PATHFAST NTproBNP - Class 2 Recall
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2018 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - Intuitive Surgical da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors - Class 2 Recall
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needl...
Source: Medical Device Recalls - September 13, 2018 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - Intuitive Surgical da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors - Class 2 Recall
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needl...
Source: Medical Device Recalls - September 13, 2018 Category: Medical Devices Source Type: alerts
Elekta, Inc. - MOSAIQ Oncology Information System - Class 2 Recall
MOSAIQ Oncology Information System (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2018 Category: Medical Devices Source Type: alerts
HYPOTHALAMUS HP (Aralia Quinquefolia, Germanium Sesquioxide, Hydrocotyle Asiatica, Hypophysis Suis, Hypothalamus Suis, Pineal Gland (Suis), Polygonum Multiflorum, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Aug 3, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 3, 2018 Category: Drugs & Pharmacology Source Type: alerts
Forte Automation Systems Inc - PATIENT POSITIONING SYSTEM - Class 2 Recall
Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2018 Category: Medical Devices Source Type: alerts
LYMPH III (Echinacea (Angustifolia), Phytolacca Decandra, Boldo, Pinus Sylvestris, Thyroidinum (Suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Naja Tripudians, Calcarea Phosphorica, Influenzinum, Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin) Liquid [BioActive Nutritional, Inc.]
Updated Date: Jun 14, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 14, 2018 Category: Drugs & Pharmacology Source Type: alerts
Siemens Medical Solutions USA, Inc. - Biograph mCT Systems: - Class 2 Recall
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceutical...
Source: Medical Device Recalls - June 9, 2018 Category: Medical Devices Source Type: alerts
For Obesity-Related Cancers, Both BMI and Weight Gain Matter
(MedPage Today) -- Still, effects differ among different tumor types (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - May 29, 2018 Category: Drugs & Pharmacology Source Type: alerts
Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts
Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts
Southwest Technologies Inc - ElastoGel(TM) - Class 2 Recall
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2018 Category: Medical Devices Source Type: alerts
