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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.

Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code HAB·February 2, 2017

Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code MWS·January 5, 2015

CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

FDA Recall
Open, Classified ·Custom Medical Specialties, Inc.·Product code FCH·September 20, 2016

ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·February 2, 2017

IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MTF·December 21, 2016

VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JGS·December 20, 2016

Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

FDA Recall
Terminated ·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016

Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

FDA Recall
Terminated ·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016

Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.

FDA Recall
Terminated ·Synthes (USA) Products LLC·Product code KWI·December 29, 2016

Transvaginal Pack, part number CMP1767

FDA Recall
Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017