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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 Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Positive Susceptibility card (AST-P638), IVD, REF 418423, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Negative Susceptibility card (AST-N233), REF 413117, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

VITEK 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt·Product code FRN--·December 17, 2003

CryoValve Pulmonary Valve and Conduit

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·December 10, 2003