FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Distal Tip Design outside scope of 510k clearance Company Name: Q’Apel Medical, Inc. Brand Name: Brand Name(s) Q’Apel Medical Product Description: Product Description 072 Aspiration System Company Announcement Fremont, CA – April…

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter

Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may contain an inert fiber identified as polypropylene fibers from the IV bag Company Name: Amneal Pharmaceuticals LLC. Brand Name: Brand Name(s) Amneal Pharmaceuticals LLC. Product Description: Product Description Ropivacaine Hydrochloride Injection,…

Early Alert: Diagnostic Intravascular Catheter Issue from Conavi

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 Conavi has issued a…

Early Alert: Intravascular PICC Catheter Issue from BD

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 BD and their subsidiary…

Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.

Summary Company Announcement Date: April 03, 2025 FDA Publish Date: April 07, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Increased frequency of reports of toxic anterior segment syndrome Company Name: Bausch + Lomb Corporation Brand Name: Brand Name(s) enVista Aspire Product Description: Product Description enVista Aspire™, enVista Envy™ and Certain enVista®…

Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Summary Company Announcement Date: April 07, 2025 FDA Publish Date: April 07, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Expanded recall 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 FOR IMMEDIATE…

Medical Devices

From simple items like tongue depressors and bedpans to complex technologies such as pacemakers, surgical implants and prosthetics, learn how FDA-regulated medical devices affect you.    Animal Welfare, Testing and Research of FDA-Regulated Products Advisory Committees Give FDA Critical Advice and the Public a Voice Prostate Cancer: Symptoms, Tests, and Treatment Contact Lenses: Safe Use of…

Pulse Oximeter Basics

Image Español中文한국의TagalogTiếng Việt We need oxygen to survive. Sometimes the amount of oxygen in the blood falls too low for the body to function well. Asthma, lung cancer, chronic obstructive pulmonary disease, the flu, and heart disease are among the health conditions that can cause oxygen levels to drop. Being at higher altitudes, where the…