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Medical Device Safety

The FDA monitors 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.

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FDA Safety Communication Publish Date
Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
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Hinihikayat ng FDA ang Publiko na Sundin ang mga Protocol sa Pagsagip sa Nabubulunan: Komunikasyong Pangkaligtasan ng FDA
s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s s
Huwag Gamitin ang Synovo Total Hip Resurfacing System: Komunikasyong Pangkaligtasan ng FDA
No. utilice el sistema de revestimiento total de cadera de Synovo: Comunicado de seguridad de la FDA
FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication
ACTUALIZACI -N: Evaluación de jeringas de plástico fabricadas en China para detectar posibles fallas en los dispositivos: Comunicado de seguridad de la FDA
UPDATE: Pagsusuri ng Mga Plastik na Hiringgilya na Gawa sa China para sa mga Potensyal na Pagpalya ng Device: Komunikasyong Pangkaligtasan ng FDA
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

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
Safety and Quality Concerns with Getinge Cardiovascular Devices - 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
Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery
OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC
Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use
Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty
Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle
InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death
Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power
Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs
Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist
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

MORE MEDICAL DEVICE RECALLS

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