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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.

BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

FDA Recall
Terminated ·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011

Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

FDA Recall
Terminated ·Vygon Corporation·Product code NZW·May 11, 2012

PrepStain Installation Kit (PreCoat), Catalog/Model # 490528

FDA Recall
Terminated ·Tripath Imaging, Inc.·Product code MKQ·March 22, 2012

Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens

FDA Recall
Terminated ·Vygon Corporation·Product code NZW·May 11, 2012

0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

FDA Recall
Terminated ·Shimadzu Medical Systems·Product code IZL·October 28, 2011

TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

FDA Recall
Terminated ·Alphatec Spine, Inc.·Product code KWP·December 9, 2010

Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

FDA Recall
Terminated ·Medacta Usa Inc·Product code JDI·October 13, 2008

Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem

FDA Recall
Terminated ·Zimmer, Inc.·Product code KWS·September 4, 2012

Alloclassic SL Shaft

FDA Recall
Terminated ·Zimmer, Inc.·Product code LZO·September 4, 2012

Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx

FDA Recall
Terminated ·Zimmer, Inc.·Product code KWS·September 4, 2012