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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.

Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

FDA Enforcement
Class II ·Ongoing·O&M HALYARD INC·June 3, 2026

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

FDA Enforcement
Class I ·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit

FDA Enforcement
Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

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

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·May 20, 2026

Aligned Medical AMS16835 Fluids Kit RX

FDA Enforcement
Class II ·Ongoing·Windstone Medical Packaging, Inc.·June 10, 2026

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

FDA Enforcement
Class I ·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

FDA Enforcement
Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

FDA Enforcement
Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 17, 2026

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

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