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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.

MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

FDA Recall
Open, Classified ·Medtronic Inc.·Product code N/A·April 30, 2020

v|tome|x L Series non-destructive testing cabinet x-ray systems

FDA Recall
Terminated ·Ge Inspection Technologies Llc·Product code RCE·September 29, 2020

REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

FDA Recall
Open, Classified ·ICU Medical, Inc.·Product code N/A·March 16, 2021

Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

FDA Recall
Open, Classified ·Arrow International Inc·Product code N/A·May 19, 2021

Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

FDA Recall
Terminated ·Cook Inc.·Product code N/A·October 8, 2021

therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

FDA Recall
Terminated ·Qiagen Sciences LLC·Product code OWG·April 8, 2020

CTSTM Essential 8 Medium

FDA Recall
Terminated ·Life Technologies Corporation·Product code N/A·June 11, 2019

ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code NA·August 21, 2019

YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

FDA Recall
Terminated ·Comet Technologies Usa Inc·Product code RCE·October 1, 2018

Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence

FDA Recall
Terminated ·Olympus Scientific Solutions Americas·Product code RBY·July 11, 2017