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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.

CryoValve Pulmonary Valve & Conduct

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·November 4, 2003

OmniDiagnost System

FDA Recall
Terminated ·Philips Medical Systems Sales & Service Region No. America·July 17, 2003

X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

FDA Recall
Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

Ami HTX.

FDA Recall
Open, Classified ·Spectral Instruments Inc·Product code RCE·May 13, 2025

Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003

Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003

Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 4430

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code 74DWF·August 8, 2003

CryoValve, Pulmonary Valve & Conduit SG

FDA Recall
Terminated ·Cryolife Inc·Product code MIE·August 18, 2003

Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part ***MicroAire Surgical Instruments, 1641 Edlich Drive, Charlottesville, VA 22911***.

FDA Recall
Terminated ·Microaire Surgical Instruments·September 23, 2003

Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.

FDA Recall
Terminated ·Roche Diagnostics Corp.·December 21, 2004