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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.

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312

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

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·June 3, 2026

GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

FDA Enforcement
Class II ·Ongoing·GE Medical Systems Information Technologies Inc·June 3, 2026

Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

Halyard, Towel Six Pack. Kit Code: AMTS70-01.

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

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

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

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

FDA Enforcement
Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·June 3, 2026

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

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