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.

Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

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

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

FDA Enforcement
Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

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

i-STAT EG7+ cartridge; List Number: 03P76-25;

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·May 6, 2026

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

FDA Enforcement
Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

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

Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817

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

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

FDA Enforcement
Class II ·Ongoing·Medtronic, Inc.·May 6, 2026

Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C

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

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

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