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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.

Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.

FDA Recall
Terminated ·Product code ECO·May 1, 2018

Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code JEY·April 5, 2018

Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

FDA Recall
Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code CCT·March 19, 2018

Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

FDA Recall
Terminated ·IntroMedic Co., Ltd. F-Rtek 6 Floor 11-25 Simindaero327beon-Gil; Dongan Anyang Korea (the Republic of)·Product code NEZ·February 15, 2017

Straumann Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099

FDA Recall
Terminated ·Straumann Manufacturing, Inc.·Product code NQA·March 23, 2018

SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·February 15, 2018

Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·June 29, 2017

LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

FDA Recall
Terminated ·Physio-Control Inc·Product code MKJ·February 1, 2019

AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

FDA Recall
Terminated ·Arrow International Inc·Product code MEB·October 2, 2018

Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System

FDA Recall
Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code LNH·December 21, 2018