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FDA Device Enforcement Reports

View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.

FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

FDA Enforcement
Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 10, 2026

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

FDA Enforcement
Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

FDA Enforcement
Class II ·Ongoing·Fresh Roast Systems Inc·June 17, 2026

BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.

FDA Enforcement
Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

Atlan A350XL. Model Number: 8621600. anesthesia workstation

FDA Enforcement
Class I ·Ongoing·Draeger, Inc.·June 10, 2026

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A

FDA Enforcement
Class II ·Ongoing·Advanced Bionics, LLC·June 10, 2026

Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320

FDA Enforcement
Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

FDA Enforcement
Class II ·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026