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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.

Penner Pacific Bathing Spa, Model Numbers 860010-1L

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

GEM Premier 5000 PAK; Part No. 00055407508.

FDA Enforcement
Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 11, 2026

Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·March 4, 2026

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·March 18, 2026

GEM Premier 5000 PAK; Part No. 00055407510.

FDA Enforcement
Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

FDA Enforcement
Class II ·Ongoing·Straumann USA LLC·April 1, 2026

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·March 4, 2026