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.

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

FDA Enforcement
Class II ·Ongoing·Merit Medical Systems, Inc.·May 6, 2026

Halyard CATH LAB kit. Model Number: SACL75AM.

FDA Enforcement
Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

FDA Enforcement
Class II ·Ongoing·Beta Bionics, Inc.·April 22, 2026

See complete list in RES, exceeds character limit. Medline Surgical Gowns

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

Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715

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

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

FDA Enforcement
Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

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

Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026