Medical Device Safety

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FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below show recent medical device recalls and other FDA safety communications. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at: 1-800-638-2041 or DICE@fda.hhs.gov.

Recent Medical Device Recalls

Device Name	Date
Bard Peripheral Vascular Inc. Recalls Halo One Thin-Walled Guiding Sheath Due to Sheath Separation, Kinking, or Tip Damage	01/30/17
bioMerieux Recalls NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results	01/27/17
Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections	01/03/17
Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization	12/16/16
Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate	12/09/16
Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating	11/30/16
SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation	11/22/16

More Medical Device Recalls

Recent Medical Device Safety Communications

FDA Safety Communication	Date
UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication	01/17/17
FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication	01/13/17
Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication	01/11/17
Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication	01/09/17
La FDA advierte a los proveedores de atención médica que no deben basarse únicamente en los resultados de la prueba serológica de IgM frente al virus del Zika; les recuerda que esperen los resultados de la prueba de confirmación antes de decidir el tratamiento del paciente: Comunicación de Seguridad de la FDA	12/22/16
FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication	12/22/16
FDA approves Essure labeling with important safety information for patients and physicians.	11/15/16

More Medical Device Safety Communications

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Recent Medical Device Recalls

Recent Medical Device Safety Communications

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