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: Plum Duo Infusion System…
Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabel Company Name: Unichem Pharmaceuticals Brand Name: Brand Name(s) Unichem Pharmaceuticals Product Description: Product Description Cyclobenzaprine Hydrochloride Tablets USP 10 mg Company Announcement FOR IMMEDIATE RELEASE – 08/27/2025–…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics UPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in…
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers
August 25, 2025 The U.S. Food and Drug Administration (FDA) is reminding health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use. The FDA is aware of reports of serious injuries and deaths with use of HBOT devices and is…
Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal
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 Lot Number UDI-DI (GTIN) CAROTID WALLSTENT MONORAIL 10.0-24 H7493915010240 08714729781097 CAROTID WALLSTENT MONORAIL…
B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter
Summary Company Announcement Date: August 19, 2025 FDA Publish Date: August 19, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence of particulate matter. Company Name: B. Braun Medical, Inc. Brand Name: Brand Name(s) Product Description: Product Description Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL…
Early Alert: Cardiac Cannula Issue from Medtronic
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 Medtronic has issued a…
Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.
Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand Name: Brand Name(s) Max Mobility/Permobil Product Description: Product Description Speed Control Dial Component Company Announcement Max Mobility/Permobil has voluntarily…
Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
Summary Company Announcement Date: August 07, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery Company Name: Tandem Diabetes Care, Inc. Brand Name: Brand Name(s) Tandem Diabetes Care, Inc. Product Description: Product…
Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings
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 Model Number UDI-DI Lot Numbers Filter SafeStar 90 Plus MP05785 04048675665762 All lot…