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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.

Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.

FDA Recall
Terminated ·Apogee Medical·Product code KMJ·January 18, 2011

10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·October 2, 2009

SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.

FDA Recall
Terminated ·Impac Medical Systems Inc·Product code IYE·March 10, 2010

Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

FDA Recall
Terminated ·Solta Medical, Inc.·Product code ONG·December 15, 2010

ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study

FDA Recall
Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code BZQ·December 21, 2010

C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

FDA Recall
Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·October 8, 2009

Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.

FDA Recall
Terminated ·Kimberly-Clark Corporation·Product code FYA·December 23, 2010

CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.

FDA Recall
Terminated ·Accuray Inc·Product code IYE·March 16, 2009

Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code LXH·September 27, 2010

Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

FDA Recall
Terminated ·Vital Images, Inc.·Product code LLZ·October 14, 2010