La FDA advierte contra el uso de silicona inyectable para delinear y mejorar la figura

[embedded content] English ¿Está considerando la posibilidad de hacerse una intervención para delinear o aumentar el tamaño de ciertas partes de su cuerpo? Tenga cuidado de no usar silicona inyectable para delinear la figura ni ningún otro producto no sancionado para alcanzar sus metas. Los rellenos dérmicos inyectables son dispositivos médicos controlados por la Administración…

Hyland’s Homeopathic Teething Tablets: Questions and Answers

Español What action did the FDA take? On October 23, 2010, the U.S. Food and Drug Administration (FDA) warned consumers to stop using and discard Hyland’s Teething Tablets; and the manufacturer recalled the product. Why did the FDA take this action? The FDA issued this warning because the use of Hyland’s Teething Tablets may pose…

GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death. Recalled Product GE Carestation 600 series anesthesia systems Model numbers 620/650/650c, A1 Serial numbers: 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002 Manufacturing Dates: August 2018 to July 2019 Distribution Dates:…

FDA 101: How to Use the Consumer Complaint System and MedWatch

Español If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it. FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch. 1. Consumer Complaint Reporting…

Vaccines Protect Children From Harmful Infectious Diseases

Image Español Vaccines are essential to getting children off to a healthy start in life. Because immunization programs of the 20th and 21st century have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They don’t realize that those infectious diseases could reemerge. If individuals choose not…

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Airway Gas Option N-CAiO (00840682104074) and CARESCAPE Respiratory Modules E-sCO (00840682104173), sCOVX (00840682104289, E-sCAiO (00840682104180), E-sCAiOV (00840682104142), E-sCAiOE (00840682104135), E-sCAiOVE (00840682104302) Serial numbers: Manufacturing Dates: June 7,…

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

Summary Company Announcement Date: January 31, 2020 FDA Publish Date: January 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description due to Microbial Contamination Company Name: Efficient Laboratories, Inc. Brand Name: Brand Name(s) Product Description: Product Description Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid Company Announcement Efficient Laboratories, Inc….

Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

On January 30, 2020, Medtronic released the first round of software updates to address some of the affected devices. Medtronic will issue additional rounds of software updates to address the remaining devices. These software updates will be installed on devices automatically. For more information, see Medtronic’s Security Bulletin. Date Issued March 21, 2019 Audience Patients…

2020 Medical Device Recalls

The list below contains recalls that were issued in 2020. 2020 Medical Device Recalls Content current as of: 01/29/2020 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/medical-device-recalls/2020-medical-device-recalls