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Medical Device Safety

The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. The lists below contain our most recent information. For additional information, contact us – Division of Industry and Consumer Education (DICE).

Recent Medical Device Safety Communications

The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.

FDA Safety Communication Publish Date
Mga May Kaugnayang Recall - Mga Plastik na Hiringgilya na Gawa sa China para sa Mga Potensyal na Pagpalya ng Device
相关召回——中国制造的塑料注射器存在潜在器械故障
Retiros relacionados: jeringas de plástico fabricadas en China para detectar posibles fallas en los dispositivos
Zimmer Biomet CPT Hip System Femoral Stem at Nadagdagang Panganib ng Bali sa Buto sa May Hita - Komunikasyong Pangkaligtasan ng FDA
Zimmer Biomet CPT 髋关节系统股骨柄可能增加大腿骨骨折风险——美国食品药品监督管理局 (FDA) 安全通报
Vástago femoral del sistema de cadera CPT de Zimmer Biomet y mayor riesgo de fracturas del fémur: Comunicado de seguridad de la FDA
Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication
Related Recalls - Plastic Syringes Made in China for Potential Device Failures
因存在假阴性或假阳性风险，请勿使用 Cue Health 公司的 COVID-19 检测产品：美国食品药品监督管理局 (FDA) 安全通报
Huwag Gamitin ang Mga Pagsusuri para sa COVID-19 ng Cue Health Dahil sa Panganib na Magkaroon ng Mga Maling Resulta: Komunikasyong Pangkaligtasan ng FDA
No utilice las pruebas de COVID-19 de Cue Health debido al riesgo de obtener resultados falsos: Comunicado de seguridad de la FDA

MORE MEDICAL DEVICE SAFETY COMMUNICATIONS

Recent Letters to Health Care Providers

Information for health care providers about the safe use of medical devices in medical facilities.

Device Name Publish Date
Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers
Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers
Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes - Letter to Health Care Providers

MORE LETTERS TO HEALTH CARE PROVIDERS

Recent Medical Device Recalls

Medical device recalls that may potentially present significant risks to consumers or users of the product.

Device Name Publish Date
IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement
Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components
Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector
Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation
Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm 
Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets
Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings
Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators
Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion
Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation
Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli
Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail
Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions
Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery
Heart Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems due to Failed Quality Inspections
Nerve Monitoring System Correction: Medtronic Issues Correction for NIM Vital Nerve Monitoring System due to the Potential for False Negative Response
Ambulatory Infusion Pump Software Correction: Smiths Medical Issues Correction for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software due to Multiple Issues Related to Outdated Software
Eye Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility
Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle
Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns
Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart
An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions

MORE MEDICAL DEVICE RECALLS

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