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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.

AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

FDA Recall
Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 S/Ns 10019, 10019, 10020, 10043, and 10052.

FDA Recall
Terminated ·Coherent, Inc.·Product code L22·January 19, 2004

NOW Malaria (Export use only) Item Number 660-430, Kit Number 66005, Kit Number 660-000

FDA Recall
Terminated ·Binax, Inc.·Product code NED·February 18, 2004

Custom Order Value Pack General Anesthesia Kit Catalog Number: VP1279 Labeled in part: CONTENTS: 1-Adult Disposable Anesthesia Breathing Circuit ***1-Breathing Bag Non-Latex***.

FDA Recall
Terminated ·Smiths Medical ASD, Inc.·April 1, 2004

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.

FDA Recall
Open, Classified ·Northeast Scientific Inc.·Product code QTF·August 29, 2025

Fusion Pro 24, Model 17000

FDA Recall
Open, Classified ·Epilog Laser Corp.·Product code RHK·August 8, 2024

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).

FDA Recall
Open, Classified ·LivaNova USA, Inc.·Product code LYJ·December 12, 2024

Lazervida 10W diode laser cutter and engraver with Lazervida shield.

FDA Recall
Open, Classified ·Flux Technology Inc.·Product code RHK·February 19, 2025

SlideView VS200 slide viewer,

FDA Recall
Open, Classified ·EVIDENT SCIENTIFIC INC·Product code RIB·July 22, 2024

Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

FDA Recall
Terminated ·Oxford Immunotec·Product code OJN·July 16, 2020