FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 6, 2025 - 08:49 GMT

Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner ...

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: Shiley …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 08:49 GMT

Anesthesia Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit 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 Part No. Product Name …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 24, 2025 - 18:50 GMT

Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

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: HeartMate …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 24, 2025 - 16:08 GMT

Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing ...

Date Issued: April 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 19, 2025 - 01:00 GMT

FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as ...

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Distal Tip Design outside scope of 510k clearance Company Name: Q’Apel Medical, Inc. Brand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 18, 2025 - 23:20 GMT

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the ...

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 April 18, 2025 - 17:14 GMT

Early Alert: Intravascular PICC Catheter Issue from BD

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 April 18, 2025 - 14:52 GMT

Early Alert: Diagnostic Intravascular Catheter Issue from Conavi

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 April 8, 2025 - 08:30 GMT

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety ...

Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions AUDIENCE: Patient, Health Care Professional, Pain Management ISSUE: In May 2025, the FDA convened …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2025 - 07:49 GMT

Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to ...

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 April 7, 2025 - 21:33 GMT

Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in ...

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 April 7, 2025 - 15:45 GMT

Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

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 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