The Food and Drug Administration July 21 identified Class I recalls of two products due to the potential for serious injury or death. Integra LifeSciences MicroMyst Applicators were recalled due to incomplete bioburden assessments and sterilization location transfer documentation. The recall involves removing devices from where they are used or sold. Maquet Critical Care AB Servo Ventilator Systems were recalled due to a risk of an inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The recall involves updating instructions for using devices. 

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The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy…
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The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F…
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The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B.…
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Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during…
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The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
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The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device…