SEO landing

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.

Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.

FDA Recall
Terminated ·Lifecor Inc·January 10, 2003

Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**.

FDA Recall
Terminated ·Shelhigh, Inc.·Product code MWH·January 18, 2006

BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ

FDA Recall
Terminated ·Becton Dickinson & Company·May 17, 2007

Laser Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769

FDA Recall
Terminated ·K Tek·Product code K--DD·November 3, 2006

CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

FDA Recall
Terminated ·LAP of America Laser Applications, LLC·October 7, 2013

CryoValve Allograft, Heart valve

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·April 30, 2003

Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]

FDA Recall
Terminated ·Bayer HealthCare LLC, Diagnostics Div·June 19, 2003

BACK PACK

FDA Recall
Terminated ·Windstone Medical, Inc.·March 25, 2003

RJ T&A PACK

FDA Recall
Terminated ·Windstone Medical, Inc.·March 25, 2003

Mammomat Novation Digital Mammography System. Model number 6646900

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·May 25, 2005