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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.

2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

2.0 mm Inion CPS, L-plate left, 7 holes, REF PLT-1040, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland.

FDA Recall
Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico

FDA Recall
Terminated ·Stryker Endoscopy·Product code HWC·August 20, 2009

PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.

FDA Recall
Terminated ·Peak Surgical·Product code GEI·May 19, 2009

Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560

FDA Recall
Terminated ·Stryker Endoscopy·Product code FAT·May 11, 2010