From simple items like tongue depressors and bedpans to complex technologies such as pacemakers, surgical implants and prosthetics, learn how FDA-regulated medical devices affect you. Animal Welfare, Testing and Research of FDA-Regulated Products Advisory Committees Give FDA Critical Advice and the Public a Voice Prostate Cancer: Symptoms, Tests, and Treatment Contact Lenses: Safe Use of…
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 Aortic Root Cannula MiAR Cannula DLP Aortic Root Cannula with Vent Line…
Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes – Letter to Health Care Providers
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…
Pulse Oximeter Basics
Image Español中文한국의TagalogTiếng Việt We need oxygen to survive. Sometimes the amount of oxygen in the blood falls too low for the body to function well. Asthma, lung cancer, chronic obstructive pulmonary disease, the flu, and heart disease are among the health conditions that can cause oxygen levels to drop. Being at higher altitudes, where the…
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…