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…
Understanding FDA Terms for Possible New Therapies to Prevent and Treat Diseases
Image The U.S. Food and Drug Administration is responsible for protecting the public health by, among other things, ensuring the safety and effectiveness of drugs, biological products and medical devices. In certain circumstances, the FDA allows the emergency use of medical products that do not yet have agency approval. The language used to describe potential…
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…
DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination
Summary Company Announcement Date: August 08, 2025 FDA Publish Date: August 09, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Contamination with Burkholderia cepacia Company Name: DermaRite Industries, LL Brand Name: Brand Name(s) DermaKleen, Dermasarra, Kleenfoam, and Perigiene Product Description: Product Description OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic…
Early Alert: WATCHMAN Access System Issue from Boston Scientific
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 Boston Scientific has issued…
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live): FDA Safety Communication
AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics ISSUE: On May 9, 2025, FDA issued a safety communication informing the public that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) jointly recommended a pause in the use of Ixchiq (Chikungunya Vaccine, Live) in individuals…
Early Alert: Electrophysiology Catheter Issue from Medline ReNewal
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 ReNewal has issued…