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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 360020-1P

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

Endo-Model Replacement Plateau; Item Number: 15-8521/15;

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

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

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·April 1, 2026

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026

GEM Premier 5000 PAK; Part No. 00055407511.

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

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

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

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

GEM Premier 5000; Part No. 00055415010.

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

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

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