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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
FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication
Evaluación de jeringas de plástico fabricadas en China para detectar posibles fallas en los dispositivos
Pagsusuri ng Mga Plastik na Hiringgilya na Gawa sa China para sa Potensyal na Pagpalya ng Device
Huwag Gumamit ng Smartwatches o Smart Rings upang Sukatin ang antas ng asukal sa Dugo: Komunikasyon sa Kaligtasan ng FDA
请勿使用智能手表或智能戒指测量血糖水平：FDA 安全通报
No utilice relojes inteligentes ni anillos inteligentes para medir los niveles de glucosa en sangre: Comunicado de seguridad de la FDA
Ilang ResMed Ltd Masks para sa BiPAP, Mga CPAP Machines na Na-recall Dahil sa Isyu sa Kaligtasan sa mga Magnet na Maaaring Makaapekto sa Ilang Mga Medikal na Device: Komunikasyon sa Kaligtasan ng FDA
因磁铁安全问题可能影响某些医疗器械，瑞思迈有限公司 (ResMed Ltd) 召回某些用于双水平气道正压通气（BiPAP）机和持续气道正压通气 (CPAP) 机的面罩：美国食品和药物管理局 (FDA) 安全通报
Ciertas mascarillas de ResMed Ltd para las máquinas BiPAP y CPAP han sido retiradas del mercado debido a problemas de inocuidad con imanes que pueden afectar ciertos dispositivos médicos: Comunicado de seguridad de la FDA
Huwag Gumamit ng Ilang Cardinal Health Monoject Luer-Lock at Enteral na mga Hiringgilya - Komunikasyon sa Kaligtasan ng FDA
请勿使用某些卡迪纳尔健康公司 Monoject 鲁尔锁注射器和肠内注射器——FDA 安全通报
No utilice determinadas jeringas Monoject Luer-Lock y Enteral de Cardinal Health: Comunicación de seguridad de la FDA
Ang Hintermann Series H3 Total Ankle Replacement ay May Mas Mataas Kaysa sa Inaasahang Panganib ng Pagpalya ng Kagamitan: Komunikasyong Pangkaligtasan ng FDA
Hintermann H3 系列全踝关节置换术器械故障风险高于预期：FDA 安全通报
El reemplazo total de tobillo Hintermann Series H3 tiene un riesgo de fallas del dispositivo superior al esperado: Comunicado de seguridad de la FDA
Mga Panganib ng Exactech Equinoxe Shoulder System na may Depektibong Packaging - Komunikasyon sa Kaligtasan ng FDA
Exactech Equinoxe 肩关节系统包装有缺陷，使用有风险——FDA 安全通报
Riesgos del sistema de hombro Equinoxe de Exactech con embalaje defectuoso: Comunicado de seguridad de la FDA
BioZorb 标记物和在乳腺组织中使用的潜在风险：FDA 安全通报
Ang BioZorb Markers at mga Potensyal na Panganib sa Paggamit nito sa Tissue sa Suso: Komunikasyon sa Kaligtasan ng FDA
Marcadores BioZorb y posibles riesgos con su uso en tejido mamario: Comunicado de seguridad de la FDA
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication

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
Follow Instructions for Safe Use of Electrical Operating Room Tables - 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
Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death
Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction
Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft
Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation
Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage
Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist
Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death
Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks
Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop
Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile Water Based Products Under Recall by Nurse Assist
Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap
Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter Disconnection from the Patient Line Stopcock Connectors
Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error
Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions
Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators
Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch
Olympus Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes for Risk of Endobronchial Combustion and Patient Burns
Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling
Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions
Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization
Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist
Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error

MORE MEDICAL DEVICE RECALLS

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