FDA Press Releases

• Published on February 14, 2025 - 17:38 GMT

  

  ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to ...

  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 February 14, 2025 - 16:55 GMT

  

  Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due ...

  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 death if you …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 10, 2025 - 16:37 GMT

  

  Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component ...

  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 Names/Models …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 6, 2025 - 16:30 GMT

  

  Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

  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 February 6, 2025 - 16:30 GMT

  

  Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub ...

  This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type, Class I. This device may cause serious injury or death if you continue to use it. Affected Product  Product Names: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on February 5, 2025 - 18:24 GMT

  

  Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• 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 …

  Distribution channels:
• 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 …

  Distribution channels:
• 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