FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 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 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

Published on March 18, 2025 - 16:51 GMT

Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with ...

The FDA has identified this recall as the most serious type. This recall involves: removing the Pipeline Vantage 027 device models from where they are used or sold updating instructions for using the Pipeline Vantage 021 device models Affected Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 14, 2025 - 20:11 GMT

Disruptions in Availability of Hemodialysis Bloodlines - Letter to Health Care Providers

March 14, 2025 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of hemodialysis bloodlines because of recent supplier issues. The disruption in supply of this device is expected to impact …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 13, 2025 - 23:37 GMT

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to ...

Summary Company Announcement Date: March 13, 2025 FDA Publish Date: March 13, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling of infusion bag Company Name: Dr. Reddy’s Laboratories Ltd. Brand Name: Brand Name(s) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2025 - 12:24 GMT

Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports ...

AUDIENCE: Patient, Health Professional, Pharmacy, Immunology ISSUE: As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 10, 2025 - 22:11 GMT

Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ...

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