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.

CryoValve, Aortic Valve & Conduit

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·December 17, 2004

Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch

FDA Recall
Terminated ·Bioteque America Inc·February 24, 2005

Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-55 (00225307055).

FDA Recall
Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

Warm Air Model 135 Warming Units.

FDA Recall
Terminated ·Cincinnati Sub-Zero Products·Product code BTE·November 5, 2004

INTELECT MOBILE COMBO, Model No. 2778, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.

FDA Recall
Terminated ·Chattanooga Corp Inc·Product code MPH·December 17, 2007

Hall Easy-Fit Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non-pyrogenic if seal and package are not opened, damaged, or broken.

FDA Recall
Terminated ·Medtronic Heart Valve Division·March 25, 2008

CryoValve Allograft heart valve

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

One heart and pericardium from donor 12144.

FDA Recall
Terminated ·DCI Donor Services Tissue Services Division·Product code MIE·August 20, 2002

Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems

FDA Recall
Terminated ·General Electric Med Systems·Product code 90LMA·November 21, 2002

JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604 Queensbury Ave., Queensbury, New York 12804 *** Single use, sterile, disposable intravascular catheters with an atraumatic tip.

FDA Recall
Terminated ·Jomed Catheters, Inc.·November 21, 2002