FDA Press Releases

• Published on April 6, 2025 - 12:01 GMT

  

  Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, 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 March 31, 2025 - 14:01 GMT

  

  Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer

  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:  DLP …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 25, 2025 - 14:13 GMT

  

  Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube ...

  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 Product …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 20, 2025 - 19:29 GMT

  

  Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care ...

  This recall involves correcting software for 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 March 20, 2025 - 17:04 GMT

  

  Update on Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

  This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 20, 2025 - 17:04 GMT

  

  Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation

  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 March 20, 2025 - 16:25 GMT

  

  Early Alert: Aspiration System Issue from Calyxo

  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 March 19, 2025 - 20:52 GMT

  

  Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause ...

  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  Item Number Product …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 18, 2025 - 16:51 GMT

  

  Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with ...

  The FDA has identified this recall as the most serious type. This recall involves: removing the Pipeline Vantage 027 device models from where they are used or sold  updating instructions for using the Pipeline Vantage 021 device models  Affected Product  …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 14, 2025 - 20:11 GMT

  

  Disruptions in Availability of Hemodialysis Bloodlines - Letter to Health Care Providers

  March 14, 2025 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of hemodialysis bloodlines because of recent supplier issues. The disruption in supply of this device is expected to impact …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 13, 2025 - 23:37 GMT

  

  Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to ...

  Summary Company Announcement Date: March 13, 2025 FDA Publish Date: March 13, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling of infusion bag Company Name: Dr. Reddy’s Laboratories Ltd. Brand Name: Brand Name(s) …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 11, 2025 - 12:24 GMT

  

  Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports ...

  AUDIENCE: Patient, Health Professional, Pharmacy, Immunology ISSUE: As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 10, 2025 - 22:11 GMT

  

  Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ...

  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 March 6, 2025 - 16:23 GMT

  

  Infusion Pump Intermittent Connection Issue from Smiths Medical

  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 March 6, 2025 - 16:23 GMT

  

  False Alarm Issue with Infusion Pump from Smiths Medical

  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 March 6, 2025 - 16:22 GMT

  

  Infusion Pump Thermal Damage Issue from Smiths Medical

  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 March 5, 2025 - 21:52 GMT

  

  Update on Alert: Solution Set Issue from Baxter Healthcare Corporation

  This communication was initially issued as part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health …

  Distribution channels:
• Published on March 5, 2025 - 21:52 GMT

  

  Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA

  This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. 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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on March 5, 2025 - 16:34 GMT

  

  Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation

  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 March 3, 2025 - 19:27 GMT

  

  Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due ...

  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. This is an expansion of the 2024 Class I …

  Distribution channels: Healthcare & Pharmaceuticals Industry