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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.

Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 29, 2026

Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

FDA Enforcement
Class I ·Ongoing·Insulet Corporation·April 22, 2026

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 8, 2026

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

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

MiniMed 530G Insulin Pump (MMT-551, MMT-751)

FDA Enforcement
Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc

FDA Enforcement
Class II ·Ongoing·Mentor Texas, LP.·April 8, 2026

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

FDA Enforcement
Class II ·Ongoing·Windstone Medical Packaging, Inc.·April 29, 2026

Yeastone Broth, 11ML, 10/BOX YY3462

FDA Enforcement
Class II ·Ongoing·Remel, Inc·April 22, 2026