Date Issued: February 5, 2025 The U.S. Food and Drug Administration (FDA) is alerting patients who use diabetes devices and their caregivers of reports where users of continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes devices did not receive or did not hear alerts from their smartphones. A missed alert…
Michigan Man Charged with Drug Distribution and Loan Fraud
BOSTON – A Michigan man has been charged and has agreed to plead guilty in connection with a conspiracy to import and sell illegal pharmaceuticals, including opioids, and to fund the operation of the scheme by fraudulently obtaining a Covid pandemic relief loan. Donald Nchamukong, 37, was charged by Information with conspiracy to smuggle goods…
Hell’s Kitchen Aesthetician Arrested For Unlawfully Injecting Counterfeit Botox
Joey Grant Luther Allegedly Purchased and Imported Counterfeit Botox From China and Administered Drugs to Clients at His Hell’s Kitchen Medical Spa Without a License Danielle R. Sassoon, the United States Attorney for the Southern District of New York, announced the unsealing of a Complaint charging JOEY GRANT LUTHER with wire fraud, smuggling, and other…
California Man Sentenced for Selling Unapproved Drugs with Intent to Defraud over the Internet
Burlington, Vermont – The Office of the United States Attorney for the District of Vermont announced that on February 3, 2025, Jeremy Brown, 55, of Simi Valley, California, was sentenced for introducing into interstate commerce new drugs not approved by the Food and Drug Administration (“FDA”) with the intent to defraud or mislead. The Honorable…
Indian National Sentenced for Conspiracy to Distribute Controlled Substances
Burlington, Vermont – The Office of the United States Attorney for the District of Vermont announced that on February 3, 2025, Nitin Mishra, 33, of Jaipur, India, was sentenced for conspiring to distribute controlled substances and distributing controlled substances, including the opioids Tapentadol and Tramadol, in connection with his involvement in an international drug trafficking…
Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
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: TRUAIRE-5 02 CONCENTRATOR Model: O2C5L Serial Numbers: All units within serial number range: JA2311000001-JA2312000740…
Update on Alert: Infusion Pump Issue from Fresenius Kabi USA
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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. The affected…
Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective 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 What to Do On December 5, 2024, Mercury Medical sent all affected customers an Urgent…
Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
This recall involves correcting certain 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 correction. Affected Product Product Names: Becker External Drainage and Monitoring…
Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating instructions for using certain 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…