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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.

Basic Kit, part number CMP1109(A

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra System malfunction warnings.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code MCX·January 31, 2017

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

FDA Recall
Terminated ·The Binding Site Group, Ltd.·Product code DEH·November 28, 2012

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

FDA Recall
Terminated ·Exactech, Inc.·Product code JDI·November 7, 2016

Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

FDA Recall
Terminated ·DICOM GRID INC·Product code LLZ·December 16, 2016

AFX Endovascular AAA System, Endoleak Type IIIA

FDA Recall
Terminated ·Product code MIH·December 27, 2016

Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System

FDA Recall
Terminated ·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code NRA·January 5, 2016

GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

FDA Recall
Terminated ·Vascular Solutions, Inc.·Product code DQO·January 12, 2017

Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label)

FDA Recall
Terminated ·Reckitt Benckiser LLC·Product code HIS·November 22, 2016