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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.

8Fr. Catheter Clamp with Fastener; Product Code: CC-00008

FDA Recall
Terminated ·Arrow International Inc·Product code DQY·April 11, 2018

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA

FDA Recall
Terminated ·Arrow International Inc·Product code DYB·April 11, 2018

SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·April 11, 2018

Percutaneous Sheath Introducer Kit with ARROWgard Blue Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS

FDA Recall
Terminated ·Arrow International Inc·Product code DYB·April 11, 2018

nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.

FDA Recall
Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·December 15, 2014

G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code HTY·May 16, 2018

ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501

FDA Recall
Terminated ·Arrow International Inc·Product code FMF·April 11, 2018

Respire Pink+ Hard Oral Sleep Apnea Device

FDA Recall
Terminated ·Product code LRK·September 1, 2017

Echogenic Introducer Needle; Product Code: AN-04318

FDA Recall
Terminated ·Arrow International Inc·Product code FMI·April 11, 2018