FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

Published on September 12, 2025 - 19:23 GMT

Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design ...

This recall involves correcting certain devices through a software update 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 September 12, 2025 - 18:30 GMT

Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed ...

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 Description Model …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2025 - 18:30 GMT

Update on Alert: Defibrillation Lead Issue from Boston Scientific

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 August 29, 2025 - 18:24 GMT

Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) 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.  Affected Product Product Name: AC Power …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2025 - 18:23 GMT

Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks ...

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 Part number …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2025 - 14:40 GMT

Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings

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 …

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Published on August 29, 2025 - 14:14 GMT

Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port

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 Do not use …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 28, 2025 - 23:40 GMT

DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination

Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety - Potential Burkholderia cepacian contamination Company Name: DermaRite …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 28, 2025 - 19:37 GMT

Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit ...

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: HAMILTON- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 28, 2025 - 19:08 GMT

Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns

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 Catalog Number Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 28, 2025 - 16:29 GMT

Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in ...

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 August 27, 2025 - 20:34 GMT

Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to ...

Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabel Company Name: Unichem Pharmaceuticals Brand Name: Brand Name(s) …

Distribution channels: Healthcare & Pharmaceuticals Industry