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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.

Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.

FDA Recall
Terminated ·Pointe Scientific, Inc.·Product code CCH·June 12, 2006

Prosorba Protein A Immunoadsorption Column

FDA Recall
Terminated ·Fresenius Hemocare, Inc.·Product code LQQ·July 11, 2003

Magic View 1000U, version VE40A. Digital Image Communication System

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·February 28, 2003

Hill-Rom Newborn bassinet; model P248

FDA Recall
Terminated ·Hill-Rom, Inc.·June 20, 2003

Blood Agar Plates, 5%, Lot 3155A.

FDA Recall
Terminated ·Hardy Media Inc Dba Hardy Diag·June 25, 2003

CryoValve, Pulmonary Valve & Conduit

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·July 15, 2004

PlusRite Mercury Vapor Lamps

FDA Recall
Terminated ·Fanlight Corporation Inc·Product code U28·March 24, 2006

BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547

FDA Recall
Terminated ·Bio-Rad Laboratories Inc·Product code NVI·November 13, 2007

Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

FDA Recall
Terminated ·Hospira Inc·Product code dxg·August 11, 2009

HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

FDA Recall
Open, Classified ·Horiba Instruments Incorporated·Product code REM·March 28, 2024