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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.

AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI

FDA Recall
Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

ROYALSILK XLARGE, Gown. Item Code 9548

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508

FDA Recall
Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019

Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code LRP·December 11, 2019

Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code LRQ·December 11, 2019

Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250

FDA Recall
Open, Classified ·Pacific Medical Group Inc.·Product code HGM·September 19, 2019