FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 23, 2025 - 16:03 GMT

Early Alert: Convenience Kit Needle Issue from Integra LifeSciences

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 information becomes available. Affected Product The FDA is aware that Integra LifeSciences has issued a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 21:48 GMT

Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers

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 December 22, 2025 - 21:48 GMT

Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter

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 The FDA is aware that …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 21:47 GMT

Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets

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 The FDA is aware that B. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 22, 2025 - 21:47 GMT

Handelnine Global Limited d/b/a as Navafresh Issues Nationwide Recall of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo),...

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 December 22, 2025 - 21:47 GMT

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps

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 December 19, 2025 - 05:00 GMT

Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

AUDIENCE: Patient, Health Care Professional, Pharmacy, Hematology ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2025 - 00:18 GMT

Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device

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 December 16, 2025 - 19:27 GMT

MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal ...

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 December 16, 2025 - 16:06 GMT

StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared ...

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 November 28, 2025 - 16:17 GMT

Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 26, 2025 - 15:59 GMT

Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

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 Products Product Names: MEGA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 25, 2025 - 15:50 GMT

Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices

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: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2025 - 20:17 GMT

Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope

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: i-View …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2025 - 20:16 GMT

Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic ...

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 November 20, 2025 - 21:36 GMT

Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations

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 November 20, 2025 - 15:14 GMT

Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits

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 LRO - Sterile Medline …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 20:50 GMT

Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

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 November 19, 2025 - 18:51 GMT

Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

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 November 13, 2025 - 22:16 GMT

Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication

Español 简体中文 (Simplified Chinese) Tagalog Update: November 13, 2025 The FDA has taken actions to address the marketing of unauthorized anti-choking devices, including issuing Warning Letters and an Import Alert. Additional information is provided below …

Distribution channels: Healthcare & Pharmaceuticals Industry