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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.

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

FDA Enforcement
Class II ·Ongoing·ReCor Medical Inc.·April 8, 2026

BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Co.·May 6, 2026

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·March 4, 2026

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

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

Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08

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

THORACIC ROBOTS, DYNJ908777B

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

Allura Xper FD10C; System Code: 722001;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

FDA Enforcement
Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

FDA Enforcement
Class II ·Ongoing·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·April 22, 2026

Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O 13. XPS, DYNJ907605

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