FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 25, 2025 - 18:02 GMT

Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices - Letter to Health Care Providers

August 25, 2025 The U.S. Food and Drug Administration (FDA) is reminding health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use. The FDA is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 25, 2025 - 16:20 GMT

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics UPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2025 - 19:09 GMT

Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device ...

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 Lot Number …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2025 - 00:37 GMT

B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection ...

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 August 15, 2025 - 19:58 GMT

Early Alert: Cardiac Cannula Issue from Medtronic

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 August 12, 2025 - 22:13 GMT

Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to ...

Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 16:34 GMT

Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) ...

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 Model Number …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2025 - 13:47 GMT

Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps

Summary Company Announcement Date: August 07, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential speaker-related issue that can trigger an error resulting in a discontinuation …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2025 - 16:00 GMT

DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products 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 July 25, 2025 - 18:00 GMT

Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address ...

This recall involve 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 without …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 24, 2025 - 21:03 GMT

Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure

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 Family Model Number UDI- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 23, 2025 - 15:25 GMT

Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment

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 Q-Link 13, product code 3156509 …

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Published on July 22, 2025 - 20:17 GMT

Early Alert: Infusion Pump Issue from Baxter

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 July 22, 2025 - 11:22 GMT

Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman ...

Craniotomy Kit DYNJ35349C 10888277858060 (EA), 40888277858061 (CASE) 24CBJ925, 24DBT405, 24FBO318 CRANI Accessory Pack DYNJ59270 10888277771512 (EA), 40888277771513 (CASE) 23JDB683, 23JDC548, 24ADB783, 24HDA822 CRANI PACK-LF DYNJ44805M 10195327506872 (EA), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 21, 2025 - 17:25 GMT

Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due ...

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 July 21, 2025 - 16:09 GMT

Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns

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 Manufacturer's Product Number …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 18, 2025 - 15:03 GMT

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

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: Adult …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 17, 2025 - 18:16 GMT

Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker ...

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 Check product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 17, 2025 - 15:36 GMT

Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord ...

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: iGo2 …

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Published on July 17, 2025 - 14:37 GMT

BD Issues Update to Voluntary Global Recall of Alaris™ and BD Alaris™ Pump Modules Serviced with Legacy Bezel Kit Assemblies

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