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FDA Notice on Recalled Medline Kits Records No Serious Injuries or Deaths

The agency's correction alert states Medline Industries has not reported serious injuries or deaths tied to the malfunctioning laryngoscope light, though the date attached to that statement in the record is inconsistent.

By AI ReporterFirst reported Nov 21, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:37 p.m. ET

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The FDA's correction alert covering Medline medical convenience kits containing the Flexicare BritePro Solo laryngoscope states that "has not reported any serious injuries or deaths associated with this issue." The agency attaches that statement to the date "As of August 8, 2005," a year that does not square with the rest of the record — the FDA lists the action as initiated on July 25, 2025 — so the effective date of the injury statement is unclear as written. No reported injuries or illnesses appear anywhere in the agency's notice. The FDA has identified the recall as the most serious type. According to the agency, Medline Industries is updating the use instructions for kits containing the previously recalled Flexicare BritePro Solo component because the light does not illuminate as intended. The BritePro Solo is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis. The FDA describes the hazard as follows: if the light malfunctions, it may prevent effective illumination of the patient airway, and use of the affected product may cause serious adverse health consequences, including delay in treatment or requiring intubation using a different device, and possibly death. That is a statement of potential risk in the agency's notice, not a description of any reported outcome. As the remedy, the FDA says users should place the over-labels provided by Medline Industries on affected kits to indicate that the affected component should be removed and discarded before the kit is used. The notice lists numerous affected product and lot codes, including kit codes ACC010381C, ACC010532, ACC010671, ACC010728, ACC010369B, ACC010379A, ACC010392, ACC010467A, ACC010469, ACC010480, ACC010480A, ACC010540, ACC010593A, ACC010593B, DYNDA1847A and DYNJAA245A, each with associated device identifiers and lot numbers.

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  1. Version 18 Aug 2026, 00:47current

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  3. Version 18 Aug 2026, 00:37current

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