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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.

VITEK 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code LON·April 20, 2017

VITEK 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code LON·April 20, 2017

Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

FDA Recall
Terminated ·GE Healthcare, LLC·Product code IXR·February 6, 2017

Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code GBX·April 21, 2017

VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code LON·April 20, 2017

VITEK 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code LON·April 20, 2017

Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code GCY·April 21, 2017

Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.

FDA Recall
Terminated ·Innovasis, Inc·Product code KWQ·May 5, 2017

Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code GBX·April 21, 2017

NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

FDA Recall
Open, Classified ·Nexstim PLC Elimaenkatu 9B Helsinki Finland·Product code GWF·March 14, 2017