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Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices

Murilo Freitas - 05:00, 24 de November de 2025177
SpeedControl Dials used with SmartDrive MX2+ Power Assist Devices may be unresponsive to users and fail to stop or start unexpectedly, causing injury

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/recall-alert-max-mobilitypermobil-removes-all-speedcontrol-dials-used-smartdrive-mx2-power-assist

 
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Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi

Murilo Freitas - 05:00, 23 de November de 2025232
Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-large-volume-pump-primary-administration-set-reverse-flow-issue-fresenius-kabi

 
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Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles

Murilo Freitas - 05:00, 20 de November de 2025165
Medline is updating labels for their medical kits containing the Flexicare BritePro Solo due to the light not illuminating as intended.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-medline-industries-lp-updates-use-instructions-medline-kits-containing-flexicare

 
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Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue

Murilo Freitas - 05:00, 19 de November de 2025164
If a user rapidly presses two or more on-screen buttons, the NOxBOXi Nitric Oxide Delivery System may experience sudden software interruption or restart.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-noxbox-ltd-issues-correction-noxboxi-nitric-oxide-delivery-system-due-rapid-command-input

 
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Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations

Murilo Freitas - 05:00, 19 de November de 2025194
There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-noxbox-ltd-issues-correction-noxboxi-nitric-oxide-delivery-system-due-risk-nitric-oxide-dosing

 
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