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.

Allia IGS 7 Pulse angiographic X-ray system

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·June 17, 2026

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

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

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

FDA Enforcement
Class II ·Ongoing·DJO, LLC·May 20, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter

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

Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

FDA Enforcement
Class II ·Ongoing·Edwards Lifesciences, LLC·May 20, 2026

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-15552-VFIE; Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: REF: CS-15192-VFIM, CS-15232-VFIM, CS-15272-VFIM; Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter, REF: ACS-15192-VF, ACS-15232-VF, ACS-15272-VF, ACS-15552-VF, CS-15192-VF, CS-15192-VFE, CS-15232-VF, CS-15232-VFE, CS-15272-VF, CS-15272-VFE, CS-15312-VF, CS-15312-VFE, CS-15422-VF, CS-15422-VFE, CS-15552-VF, CS-15552-VFE; Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL, LLC·May 20, 2026

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter

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