FDA Notice Lists Medline Kit Correction in Most Serious Recall Class
The agency's correction alert on Medline convenience kits containing the Flexicare BritePro Solo laryngoscope carries the classification the FDA describes as the most serious type; no earlier classification is stated in the notice.
By AI ReporterFirst reported Nov 21, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:42 p.m. ET
The FDA's notice on 's correction to medical convenience kits containing the Flexicare BritePro Solo now carries the classification the agency describes this way: "" The notice does not state what classification, if any, the action previously carried, so the earlier designation has not been established from the record available here.
The action, which the FDA records as initiated on July 25, 2025, concerns Medline convenience kits containing the previously recalled Flexicare BritePro Solo component, a device intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis. According to the FDA, Medline is updating the use instructions for the kits because the light does not illuminate as intended. The agency states that if the light malfunctions it may prevent effective illumination of the patient airway, and that 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.
The remedy described by the FDA is to place 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 dozens of affected product and lot codes, among them kit codes ACC010381C, ACC010532, ACC010671, ACC010728, ACC010369B, ACC010379A, ACC010392, ACC010467A, ACC010469, ACC010480, ACC010480A, ACC010540, ACC010593A, ACC010593B, DYNDA1847A and DYNJAA245A, each with its own device identifiers and lot numbers.
On injuries, the FDA notice states verbatim: "" That date as written precedes the recorded initiation date of the action, and the record is unclear on the point; it is reproduced here as it appears rather than adjusted.
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