Date Issued: September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern….
Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery
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 Product Name: Intera 3000 Hepatic Artery Infusion Pump Models: See Recall Database entry Devices Recalled in the U.S.: 50 Dates distributed: August 12, 2021 to May 17,…
Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop
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 Product Name: HAMILTON-C6 Intensive Care Ventilator Product Model Numbers: See Recall Database entry Devices Recalled in the U.S.: 497 Dates distributed: August 31, 2017 to May 20,…
Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication
Date Issued: August 29, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the…
Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure
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 Product Name: Medtronic HVAD Batteries Model Numbers: 1650DE Devices Being Recalled: 23,372 Dates distributed: January 1, 2009 to present Date Initiated by Firm: June 28, 2022 Device…
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates
Summary Company Announcement Date: August 22, 2022 FDA Publish Date: August 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible particulate Company Name: Hospira, Inc., a Pfizer Company Brand Name: Brand Name(s) Product Description: Product Description Propofol Injection Emulsion, USP Company Announcement FOR IMMEDIATE RELEASE -NEW YORK, NY., August…
Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy
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 Product Name: Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) Model Numbers (See recall database entry for more information): Cobalt…
At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
Date Issued: August 11, 2022 Perform repeat, or serial testing following a negative result on any at-home COVID-19 test, whether or not you have symptoms. The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk…
Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery
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 Product Name: BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, BD Intraosseous Powered Drivers Product Codes: See recall database entry Devices Recalled in the U.S.:…
Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA
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 Product Name: Viral Transport Media Containers Brand names HXBL, WETEX, or Genesis Biomedical, with part numbers HX-K59, HX-K59-1, and “custom made” (saline). Product Serial Numbers: Distribution Dates:…