SEO landing

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.

Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

FDA Enforcement
Class II ·Ongoing·Daavlin Distributing Company·June 10, 2026

Halyard, Pain Pack. Kit Code: AMPK48-01.

FDA Enforcement
Class II ·Ongoing·AVID Medical, Inc.·June 17, 2026

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

FDA Enforcement
Class II ·Ongoing·Becton, Dickinson and Company·May 27, 2026

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320

FDA Enforcement
Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

FDA Enforcement
Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter

FDA Enforcement
Class II ·Ongoing·Medtronic Perfusion Systems·May 27, 2026

MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

FDA Enforcement
Class II ·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter

FDA Enforcement
Class II ·Ongoing·Medtronic Perfusion Systems·May 27, 2026

Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320

FDA Enforcement
Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026