FDA Press Releases

• Published on February 5, 2025 - 17:03 GMT

  

  Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming ...

  This recall involves correcting 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 …

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• Published on February 5, 2025 - 16:09 GMT

  

  FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or ...

  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 …

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• Published on February 3, 2025 - 17:02 GMT

  

  Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2025 - 20:28 GMT

  

  Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2025 - 18:09 GMT

  

  Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2025 - 16:27 GMT

  

  Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2025 - 16:27 GMT

  

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2025 - 16:27 GMT

  

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 31, 2025 - 16:27 GMT

  

  Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 30, 2025 - 20:55 GMT

  

  Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 30, 2025 - 18:28 GMT

  

  Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication

  Date Issued: January 30, 2025  The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers, health care facilities, patients, and caregivers that cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 30, 2025 - 17:31 GMT

  

  Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and ...

  This recall involves correcting 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 24, 2025 - 20:29 GMT

  

  Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 22, 2025 - 21:44 GMT

  

  Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication - FDA Adds Boxed Warning About a Rare but Serious Allergic ...

  [Posted 01/22/2025] AUDIENCE: Patient, Health Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 17, 2025 - 20:43 GMT

  

  Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 16, 2025 - 21:17 GMT

  

  Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA

  This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 16, 2025 - 16:35 GMT

  

  Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers

  January 16, 2025 The U.S. Food and Drug Administration (FDA) is providing an update on its evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators. Based on the FDA's review of the totality of the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 15, 2025 - 16:36 GMT

  

  Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView ...

  The devices described in this recall are included in the related Letter to Health Care Providers. See the Letter to Health Care Providers for the most current information on these devices. This recall involves updating instructions for using devices, and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 13, 2025 - 16:41 GMT

  

  Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on January 7, 2025 - 21:33 GMT

  

  FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety ...

  [Posted 1/7/2025] AUDIENCE: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by …

  Distribution channels: Healthcare & Pharmaceuticals Industry