Medline Industries, LP has issued an urgent revision to the use instructions for Medline medical convenience kits containing the Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. This correction comes in response to potential risks associated with the device’s performance and aims to prevent serious adverse health outcomes. The Food and Drug Administration (FDA) categorized this recall as high-risk, citing that improper use may lead to severe injury or even death.
What changed and who is affected?
The recall primarily affects Medline medical convenience kits that include the Flexicare BritePro Solo device. These kits are commonly used for direct laryngoscopy procedures, enabling healthcare providers to view the vocal cords and glottis by illuminating the airway. Medline has identified that the lighting functionality of the BritePro Solo may not work as intended, potentially causing delayed treatment or requiring alternative measures during intubation.
Healthcare professionals and organizations using these kits must immediately update their procedures to adhere to the revised instructions provided by Medline. This involves placing over-labels supplied by Medline on affected kits, indicating that the Flexicare BritePro Solo component should be removed and discarded before use.
Updated instructions for affected kits
On July 25, 2025, Medline Industries sent notification of this recall to all impacted customers. The communication included the following key actions:
- Stock review: Check inventory for affected item and lot numbers listed within the recall portal. Quarantine any impacted products.
- Recall response form: Complete and return the form detailing the quantity of affected products in inventory. Submit the form even if no impacted products are present.
- Over-label distribution: Upon submission of the response form, Medline will provide over-labels with clear instructions for staff to remove and discard the affected component. These labels are sent via FedEx overnight where applicable.
- Customer notification: Inform any individuals or organizations to whom the kits were resold or transferred about this recall. Include their quantities on the response form.
What are the risks?
Medline has stated that the Flexicare BritePro Solo’s lighting malfunctioning prevents effective illumination of the airway during use. This could lead to complications such as delay in treatment, needing to switch to different intubation devices, or even fatal outcomes for patients.
As of August 8, 2005, Medline Industries reported no serious injuries or deaths associated with this issue. Nevertheless, the FDA has emphasized the critical need for compliance with the updated instructions to mitigate potential risks.
How can healthcare providers address concerns?
Healthcare professionals with questions or quality issues relating to this recall can contact Medline Industries directly:
- Phone: Medline Recall Department at 866-359-1704
- Email: recalls@medline.com
Additionally, adverse reactions or quality defects experienced using these devices may be reported to MedWatch: the FDA Safety Information and Adverse Event Reporting Program.
Actions required to ensure patient safety
Healthcare organizations using affected Medline convenience kits must quarantine impacted products, update staff training on the revised instructions, and actively communicate recall details to downstream users. Following these steps helps prevent misuse and ensures compliance with FDA recommendations.
Disclaimer
This content is provided for informational purposes only and should not be considered legal or professional medical advice. Healthcare providers must adhere to regulatory guidelines and manufacturer instructions.
FDA Announcement
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-medline-industries-lp-updates-use-instructions-medline-kits-containing-flexicare