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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.

Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.

FDA Recall
Terminated ·SANRAI INTERNATIONAL LLC·Product code CAF·August 29, 2018

VITEK 2 AST-N351 Test Kit

FDA Recall
Terminated ·bioMerieux, Inc.·Product code LON·December 13, 2018

HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)

FDA Recall
Open, Classified ·The Magstim Company Limited Spring Gardens Whitland United Kingdom·Product code OBP·October 25, 2018

Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

FDA Recall
Terminated ·Ossur Americas·Product code HAX·June 21, 2018

US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.

FDA Recall
Terminated ·US Endoscopy Group Inc·Product code PKL·February 4, 2019

BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·June 12, 2019

ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.

FDA Recall
Terminated ·TiSport, Llc·Product code IOR·September 11, 2018

Kit BD Max ExK TNA 2; Catalog # 442825

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

FDA Recall
Terminated ·Aniara Diagnostica LLC·Product code LCO·July 19, 2019