Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold over-the-counter (OTC) do not have FDA marketing authorization, meaning the FDA has not…
Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas
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 Medline has issued a…
Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
This recall involves 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 correction. Affected Product Product Names: Micro Joystick R-net Multi…
BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
Summary Company Announcement Date: September 12, 2025 FDA Publish Date: September 15, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Pump performance variations compared to the performance described in the user manual could impact infusion delivery Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description BD Alaris Pump Module model…
Update on Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves 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…
Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
This recall involves correcting certain devices through a software update 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 Product Names:…
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
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 Description Model Number UDI-DI DreamStation Auto CPAP UDSX500S11F 00606959423314 DreamStation Auto BiPAP UDSX700S11F 00606959423338…
DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Burkholderia cepacian contamination Company Name: DermaRite Industries Brand Name: Brand Name(s) Product Description: Product Description Hand Sanitizers, Cleansers, Skin Protectants, Deodorant Company Announcement DermaRite Industries, LLC is…
Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board
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: HAMILTON-C6 ventilator Unique Device Identifier (UDI)/Model: UDI: 76300028PN160021ZW Model: 160021 Lot/Serial Numbers: 13636–13950…
Properly Store Nicotine Pouches to Prevent Accidental Exposure to Children and Pets
Image Nicotine pouches can be dangerous to children if they use, touch, chew on, or eat them. These small fiber pouches, which contain nicotine that is chemically synthesized or derived from the tobacco leaf, can cause nicotine poisoning in children. It’s important to keep these products away from kids and to be prepared in case…