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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.

Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

GEM Premier 5000; Model No. 00055430010.

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

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

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

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

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

Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

FDA Enforcement
Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·April 22, 2026

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 18, 2026

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

FDA Enforcement
Class I ·Ongoing·Philips Respironics, Inc.·April 1, 2026

GEM Premier 5000; Part No. 00055415008.

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

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

FDA Enforcement
Class II ·Ongoing·Encore Medical, LP·March 4, 2026

Impella RP Flex with SmartAssist. Product Code: 1000323.

FDA Enforcement
Class I ·Ongoing·Abiomed, Inc.·March 11, 2026