UPDATE: On September 18, 2024, Zimmer Biomet sent a follow-up letter to U.S. surgeons that included the FDA’s recommendations from this safety communication, a plain language communication that surgeons can share with patients, and plans for the CPT Hip System Femoral Stem to be exited in the U.S. Date Issued: September 17, 2024 The U.S….
2024 Medical Device Recalls
Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components 09/24/2024 Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector 09/20/2024 Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On June 13, 2024, the FDA granted accelerated approval to…
Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle
Summary Company Announcement Date: September 20, 2024 FDA Publish Date: September 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Glass Particle Company Name: Gilead Sciences, Inc. Brand Name: Brand Name(s) Product Description: Product Description Veklury (remdesivir) for Injection Company Announcement FOR IMMEDIATE RELEASE – Foster City, Calif., September…
Do You Need a Device That Claims to Clean a CPAP Machine?
Image Español If you use a continuous positive airway pressure or CPAP machine to help you breathe during sleep, you know it can be difficult to keep up a regular cleaning schedule. A dirty CPAP machine, air filter, hoses or mask contaminated with germs, like viruses and bacteria, can make you sick. So automated machines…
Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes – Letter to Health Care Providers
July 9, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities to stop using NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes by Medtronic. These neural integrity monitor (NIM) electromyogram (EMG) endotracheal tubes are used during surgery to provide an airway for patient ventilation…
FDA D.I.S.C.O. Burst Edition: FDA approval of Retevmo (selpercatinib) for advanced or metastatic RET fusion-positive thyroid cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On May 29, 2024, the FDA granted accelerated approval to…
Safely Soothing Teething Pain in Infants and Children
[embedded content] Español Teething is a normal experience for infants and children, but it can be painful. Many well-meaning parents and caregivers who want to ease a child’s pain might turn to products that could be harmful. Soothing children’s gums with prescription or nonprescription medicines containing benzocaine or lidocaine – or homeopathic tablets and other…
Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Life2000 Ventilator Unique Device Identifier (UDI): 00887761978089 What to Do Make sure there…
Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label
Summary Company Announcement Date: July 18, 2024 FDA Publish Date: July 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabeling Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Healthy Living Product Description: Product Description Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets…