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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

FDA Recall
Terminated ·Boston Scientific Corporation·Product code JCT·March 18, 2016

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LBS·March 17, 2016

CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MCH·December 22, 2015

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

FDA Recall
Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code IXW·April 1, 2016

Cover Screw, Headless Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code DZE·November 25, 2015

Certain Implant Straight Cover Screw Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code DZE·November 25, 2015

Implant Cover Screw Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code DZE·November 25, 2015

Certain Micromini Flat Implant Cover Screw Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code DZE·November 25, 2015

O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code DZE·November 25, 2015

Conical Abutment Gold Standard ZR TM Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015