UPDATES: Starting in September 2024, Megadyne communicated in a letter to new and existing customers reiterating the use of affected devices in patients aged 12 years and older. Additionally, Megadyne’s letter informs customers that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no…

This recall involves updating instructions for using devices, and does not involve removing them 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 without following the updated instructions. Affected Product Product Names:…

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….

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…

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…

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…

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…

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…

This recall involves removing 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 Names: Medline Sub-G Endotracheal Tube with Subglottic Suctioning  Unique Device Identifier (UDI)/Model: This recall includes…

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: Vaporizer Sevoflurane Maquet Filling Product Code: 6682282 Distributed Serial Numbers: 17003 – 23454 Devices Recalled in the U.S.: 120 Dates Distributed: February 2, 2022 to…