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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.

GEM Premier 5000; Part No. 00055445004.

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

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

FDA Enforcement
Class II ·Ongoing·DEPUY (IRELAND)·May 6, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·April 15, 2026

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·April 15, 2026

Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 29, 2026

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 13, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

SIGNA Premier systems

FDA Enforcement
Class II ·Ongoing·GE Healthcare LLC·April 8, 2026

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

FDA Enforcement
Class I ·Ongoing·B Braun Medical Inc·April 22, 2026