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.

Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-25.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-110.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-200.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-50.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.

FDA Recall
Terminated ·Lumitex Inc·Product code FDG·July 1, 2009

Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

FDA Recall
Terminated ·SeaSpine, Inc·Product code KWP·March 4, 2009

Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-500-025.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrobial silver ExFen catheter, sterile, REF 8531-200-025.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).

FDA Recall
Terminated ·Newport Medical Instruments Inc·Product code CBK·December 15, 2008