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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.

ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

FDA Recall
Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242

FDA Recall
Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code DTL·December 5, 2006

Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·October 6, 2005

UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 68 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code KWL·October 26, 2007

Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.

FDA Recall
Terminated ·Medtronic Neuromodulation·Product code LKK·January 16, 2008

Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N 7211120, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007

Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code KWL·October 26, 2007

Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007

Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code KWL·October 26, 2007