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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.

BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·July 31, 2013

Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  multiple infusions of fluids, medications, or chemotherapy  infusion of fluids that are hypertonic, hyperosmolar, or have  divergent pH values  frequent blood sampling or blood/blood component infusions  infusion of incompatible medications  central venous pressure monitoring  lack of usable peripheral IV sites  replacement of multiple peripheral sites for IV access  injection of contrast media  When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.

FDA Enforcement
Class II ·Terminated·Arrow International Inc·March 21, 2018

NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

FDA Enforcement
Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 21, 2018

Sterile Custom Packs to be used in surgical procedures.

FDA Enforcement
Class II ·Terminated·American Contract Systems·June 10, 2020

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

FDA Enforcement
Class II ·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·March 21, 2018

ARTISTE" MV System

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 29, 2017

BD AffirM VPIII Microbial Identification Test

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·March 8, 2017

Amplatz Ultra Stiff Wire Guide

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 21, 2018

T/Pump temperature therapy pump, Models TP700 and TP700C

FDA Enforcement
Class III ·Terminated·Stryker Medical Division of Stryker Corporation·March 21, 2018

Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 27, 2013