Medical Devices

Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Medical Device Safety Communications

Medical Device Safety CommunicationDate
FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication 03/09/17
FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication 03/08/17
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
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 (English) 12/22/16
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 (en Español) 12/22/16
UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication 10/13/16
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication 10/11/16
The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication 09/07/16
Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication 09/01/16
Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication 08/25/16
FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Communication 08/17/16
The FDA Recommends Against Using OxySure Portable Emergency Oxygen System, Model 615: FDA Safety Communication 03/29/16
Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication 03/15/16
Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication 02/25/16
PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication 02/19/16
The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience Packs and Trays: FDA Safety Communication (English) 01/05/16
La FDA le recomienda a los proveedores de servicios de salud detener el uso de los paquetes y bandejas con material quirúrgico de Customed, Inc.: Comunicación de Seguridad de la FDA (en Español) 01/05/16
FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication 12/23/15
Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication 12/22/15
Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication 11/23/15
Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication 10/15/15
Cranial Perforators with an Automatic Clutch Mechanism, Failure to Disengage: FDA Safety Communication 09/28/15
Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication 09/17/15
Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication 08/05/15
Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication 08/04/15
Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication 07/31/15
Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety Communication 07/13/15
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication 05/28/15
Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety Communication 05/13/15
Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication 03/26/15
Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication 02/19/15
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 – FDA Safety Communication 01/21/15
UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication 11/24/14
Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint as a Dermal Filler 08/05/14
Product Shortage of Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication 05/23/14
Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication 05/07/14
Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results: FDA Safety Communication 04/29/14
Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography: FDA Safety Communication 12/12/13
Philips HeartStart Automated External Defibrillators (AED): FDA Safety Communication 12/03/13
Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO): FDA Safety Communication 10/17/13
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication 06/13/13
Stolen Covidien Surgical Stapler Reloads: FDA Safety Communication 05/07/13
Damaged or Worn Covers for Medical Bed Mattresses Pose Risk of Contamination and Patient Infection: FDA Safety Communication 04/19/13
Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Updated FDA Safety Communication 03/27/13

Medical Device Safety Archive

The articles, patient alerts, safety communications and public health notifications in the sections below are no longer being reviewed or updated. The information in them may no longer be correct. Items that have been replaced will have a link to up-to-date information


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Page Last Updated: 03/21/2017
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