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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also…
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.
Let the Science Do the Science – S.D.N.Y Torches Every Benzene Theory in OTC Acne MDL
Global Mix Inc. Recalls Niwali Tejocote Capsules and Niwali Tejocote Pieces Because of Possible Health Risk
Global Mix Inc. of Middle Village, New York, is recalling niwali Tejocote Capsules (90 capsules, Herbal Supplement) and niwali Tejocote Pieces (90 Day Supply, Herbal Supplement) because FDA analysis has determined that the products appear to be Thevetia peruviana, or yellow oleander. All parts of th
California’s Recent Gilead Decision Explains Why “Pre-Approval” Tort Claims Don’t, and Shouldn’t, Exist
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met…
A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil
Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional. These undeclared ingredients ma
Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Unsweetened Apple Sauce
KEASBEY, N.J. (Sept. 14, 2026) –Wakefern Food Corp. has voluntarily recalled select containers of Wholesome Pantry Organic Unsweetened Apple Sauce after routine FDA testing identified elevated patulin levels that exceed food safety limits and do not meet Wakefern's quality standards
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access…
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cooperative powered surgical assist device for ENT surgery. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also…
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the…
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial…
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of…
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the extravascular support for an arteriovenous fistula for vascular access. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also…
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the vaginal hydrogel packing system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing…
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the mechanical deviation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We…
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by…
BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect
On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers. O
BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) Devices with Firmware G3-2.00.76 Configured with G3 A20-31.cfg
On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers