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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.

See Luer Cap Set, MPC-130, set, administration, intravascular

FDA Enforcement
Class II ·Ongoing·Molded Products Inc·April 15, 2026

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 1, 2026

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026

Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

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

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

GEM Premier 5000; Part No. 00055445010 & 00055445011.

FDA Enforcement
Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·February 11, 2026