FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

Published on October 15, 2025 - 15:30 GMT

Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

Date Issued: October 15, 2025 The U.S. Food and Drug Administration (FDA) is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses of radiofrequency (RF) microneedling devices. These …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 11, 2025 - 00:39 GMT

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment ...

AUDIENCE: Patient, Health Care Professional, Pharmacy, Gastroenterology ISSUE: The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI. Reports were received from clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 10, 2025 - 14:38 GMT

Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

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 September 29, 2025 - 18:39 GMT

Recall and Alert Resources

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 29, 2025 - 18:39 GMT

What is an Early Alert?

On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot to minimize the time between the FDA’s initial awareness of a potentially high-risk medical device removal or correction and the agency’s public …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 29, 2025 - 18:39 GMT

What is a Medical Device Recall?

When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place. Correction - Addresses a problem with a medical device in the place where it is used or sold. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 29, 2025 - 13:11 GMT

Update on Alert: Infusion Set Performance Issue from BD

BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site 10015012 Table 1, Column B BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 2432-0007 Table 1, Column …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 24, 2025 - 20:12 GMT

Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System

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 September 24, 2025 - 17:10 GMT

Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic ...

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: ViziShot 2 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2025 - 18:43 GMT

Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

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 issue. The FDA will keep the public informed and update this web page as significant new information …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 22, 2025 - 18:02 GMT

Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles

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 September 18, 2025 - 18:29 GMT

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025

Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking AUDIENCE: Consumer, Health Care Professional, Pediatrics, Family Practice, Neurology ISSUE: The FDA is warning retailers …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 18, 2025 - 18:29 GMT

Early Alert: TactiFlex Ablation Catheter Issue from Abbott

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 issue. The FDA will keep the public informed and update this web page as significant new information …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 16, 2025 - 22:51 GMT

Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication

Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers, and health care providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs (such as heart or pulse …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 16, 2025 - 21:38 GMT

Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication

Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 16, 2025 - 17:10 GMT

Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error

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 September 16, 2025 - 14:10 GMT

Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas

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 September 15, 2025 - 19:06 GMT

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker ...

Catalog Catalog# Description UDI-DI 1000911 t:slim X2 GS, Replacement, Refurbished 00853052007318 1003808 t:slim X2 GS Classic, Replacement, Refurbished 00853052007981 1004219 t:slim X2, Basal-IQ, mg/dl 00853052007998 1004484 Pump, t:slim X2, Clinical Use …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 15, 2025 - 19:06 GMT

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets

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