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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.

AMT Initial Placement Dilator Set. Used to place gastrostomy devices.

FDA Enforcement
Class II ·Completed·Applied Medical Technology Inc·July 10, 2024

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

FDA Enforcement
Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

ARTIS Pheno VE30A and VE40A, Model 10849000

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 22, 2026

GEM Premier 5000 PAK, Part No. 00055360004.

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

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

FDA Enforcement
Class II ·Ongoing·Clinical Innovations, LLC·May 6, 2026

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

FDA Enforcement
Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

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

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

FDA Enforcement
Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026