Summary Company Announcement Date: October 31, 2025 FDA Publish Date: November 03, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for endobronchial combustion Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description Bronchofiberscopes and bronchovideoscopes Company Announcement CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced…

Date Issued: October 15, 2025 The U.S. Food and Drug Administration (FDA) is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses of radiofrequency (RF) microneedling devices. These devices use an array of small electrodes, also known as microneedles, to deliver RF energy into and under the…

This recall involves correcting 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 Code(s) Product Description(s) UDI-DI(s) Impacted Serial Numbers…

AUDIENCE: Patient, Health Care Professional, Pharmacy, Gastroenterology ISSUE: The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI. Reports were received from clinical trials and postmarketing adverse event data. Patients with IEC-EC presented with severe or prolonged diarrhea, abdominal pain, and weight loss requiring total parenteral nutrition….

Summary Company Announcement Date: October 07, 2025 FDA Publish Date: October 07, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for defective LCD displays that can affect product performance Company Name: Trividia Health, Inc. Brand Name: Brand Name(s) TRUE METRIX Product Description: Product Description Blood Glucose Meters Company Announcement (FT. LAUDERDALE,…

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…

On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot to minimize the time between the FDA’s initial awareness of a potentially high-risk medical device removal or correction and the agency’s public communication of what was potentially a high risk recall, the most serious kind of recall. While the…

When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place. Correction – Addresses a problem with a medical device in the place where it is used or sold. Removal – Addresses a problem with a medical…

Summary Company Announcement Date: September 19, 2025 FDA Publish Date: September 22, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device Components May Detach During Procedures Company Name: Olympus Corporation Brand Name: Brand Name(s) Product Description: Product Description ViziShot 2 FLEX (19G) EBUS -TBNA needles Company Announcement CENTER VALLEY, Pa., (September 19,…

This recall involves updating instructions for using 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 following the updated instructions.     Affected Product…