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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.

US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082

FDA Recall
Open, Classified ·Flowonix Medical Inc·Product code LKK·December 24, 2019

PICC Set- PR-35052-HPHNM

FDA Recall
Terminated ·Arrow International Inc·Product code LJS·December 20, 2019

NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

FDA Recall
Terminated ·Abbott Vascular·Product code LOX·January 29, 2020

Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB

FDA Recall
Terminated ·Arrow International Inc·Product code LJS·December 20, 2019

Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.

FDA Recall
Open, Classified ·Medtronic CoreValve LLC·Product code DTI·January 14, 2020

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

FDA Recall
Terminated ·Abbott Vascular·Product code LOX·January 29, 2020

Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)

FDA Recall
Open, Classified ·Flowonix Medical Inc·Product code LKK·December 24, 2019

HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

FDA Recall
Terminated ·TELEFLEX MEDICAL INC·Product code BTT·December 13, 2019

Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

FDA Recall
Terminated ·Medline Industries Inc·Product code OJH·January 21, 2020

Achieva XR. Model (REF) Numbers 781153, 781253.

FDA Recall
Open, Classified ·Philips North America·Product code LNI·January 3, 2024