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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.

Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions

FDA Recall
Terminated ·Spectranetics Corporation·Product code MCW·June 6, 2017

DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

FDA Recall
Terminated ·Medtronic Perfusion Systems·Product code DTL·June 22, 2017

9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

FDA Recall
Terminated ·Pentax of America Inc·Product code GCW·April 13, 2017

BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

FDA Recall
Terminated ·Becton Dickinson & Company·Product code FMF·September 16, 2016

Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

FDA Recall
Terminated ·Medtronic Navigation, Inc.·Product code PGW·June 29, 2017

ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

FDA Recall
Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

Alcon Custom Pak

FDA Recall
Terminated ·Alcon Research, LTD. 9965 Buffalo Speedway·Product code LRO·August 8, 2017

Plum 360 Infusion System

FDA Recall
Terminated ·ICU Medical Inc·Product code FRN·June 15, 2017

EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01

FDA Recall
Terminated ·Exactech, Inc.·Product code HTX·May 25, 2017

Maximal Barrier Drape; Product Code: ASK-01000-UPMS

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