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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.

Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians

FDA Recall
Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MWI·October 1, 2019

POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

FDA Recall
Terminated ·POM Medical LLC·Product code BYG·July 11, 2018

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

FDA Recall
Open, Classified ·Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland·Product code LOX·September 3, 2019

BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·May 13, 2019

BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·May 13, 2019

PORT AND IO ACCESS DRESSING KIT DT15780A

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code OXQ·April 24, 2019

BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·May 13, 2019

BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JKA·May 13, 2019

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

FDA Recall
Open, Classified ·Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland·Product code LOX·September 3, 2019

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case

FDA Recall
Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019