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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.

XP-XP Tibial Tray - Interlok 91mm Item # 195761

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

FDA Enforcement
Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 4, 2012

GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·April 17, 2013

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049

FDA Enforcement
Class II ·Terminated·Covidien LLC·July 8, 2015

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.

FDA Enforcement
Class II ·Terminated·Edwards Lifesciences, LLC·August 22, 2012

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 19, 2020

Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

FDA Enforcement
Class II ·Terminated·Med Tec Inc·January 21, 2015

Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.

FDA Enforcement
Class II ·Terminated·Stelkast Co·April 17, 2013

Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P

FDA Enforcement
Class II ·Terminated·Covidien LLC·July 8, 2015

Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461

FDA Enforcement
Class II ·Ongoing·Respironics California, LLC·February 19, 2020