SEO landing

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.

Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.

FDA Recall
Open, Classified ·Exactech, Inc.·Product code JWH·January 27, 2020

MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC152040-V, and VFC152060-V. Product Usage: . The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

FDA Recall
Terminated ·Microvention, Inc.·Product code HCG·November 22, 2019

Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

FDA Recall
Terminated ·Medline Industries Inc·Product code LRP·January 7, 2020

AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020