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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.

SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073

FDA Recall
Terminated ·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017

Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.

FDA Recall
Terminated ·Halyard Health, Inc·Product code BSY·October 6, 2017

RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code KRO·June 5, 2017

CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

Capnostream20 (INTL) M, CS08654

FDA Recall
Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018

Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657

FDA Recall
Terminated ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018

BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

FDA Recall
Terminated ·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MNM·September 21, 2018

CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code BSO·July 20, 2018