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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.

HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

FDA Recall
Terminated ·Thoratec Corporation·Product code DSQ·March 30, 2017

INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory

FDA Recall
Terminated ·Teleflex Medical·Product code GCD·April 21, 2017

System Console, Single Port, with irrigation Product Usage: Electric system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code KDG·March 30, 2017

System Console, Single Port, no irrigation

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code GET·October 6, 2016

Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

FDA Recall
Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JWY·January 1, 2017

Electric Handpiece EM Hand Control Product Usage: Electric system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBC·October 6, 2016

Autolube-III Product Usage: Pneumatic system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code GEY·October 6, 2016

RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306

FDA Recall
Terminated ·Siemens Healthcare Diagnostics Inc·Product code CHL·April 10, 2017

11.0cm Long Attachment Product Usage: Pneumatic system

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016