UPDATE: March 2025 The FDA is providing an update that Megadyne has communicated in a letter the availability of a labeling (pad printing) update for Megadyne Mega Soft Universal (0845 & 0846) and Universal Plus (0847 & 0848) Reusable Patient Return Electrodes. The pad printing will now show the updated indication which is for patients…
Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
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 Code UDI TRACHEAL TUBE SILICONISED ORAL/NASAL UNCUFFED 2.5MM 10/BX 100/111/025 15019315018848 TRACHEAL…
Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation
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 Name and Description UDI 21-4153-24 ProPort (Plastic standard portal) 1.9 mm PUR…
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 identified this recall as the most serious type. This device may cause serious injury…
Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load
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 without correction. Affected Product (Include the following information) Product Names:…
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 information becomes available. Affected Product The FDA is aware that Calyxo has issued a…
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 may cause serious injury or death if you continue to use it. The affected…
Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid Deformation
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 Product Names: Removal of unused: Pipeline Vantage Embolization Device with Shield Technology, 027 Compatible (Pipeline Vantage…
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 patient care and as such may require adjustments to the clinical management of patients receiving…
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 Mislabeling of Infusion Bag
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) Dr. Reddy’s Product Description: Product Description Levetiracetam in Sodium Chloride Injection Company Announcement Dr. Reddy’s Laboratories Ltd. (BSE: 500124,…