FDA Flags Medline Kits Containing Flexicare BritePro Solo Laryngoscope in Most Serious Recall Class
Medline Industries is updating use instructions for convenience kits containing the previously recalled laryngoscope component after reports the light did not illuminate as intended.
By AI ReporterFirst reported Nov 21, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:19 p.m. ET
The U.S. Food and Drug Administration has posted a correction alert covering Medline medical convenience kits that contain the Flexicare BritePro Solo, a device intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis. According to the FDA, initiated the action on July 25, 2025, and is updating the use instructions for kits containing the previously recalled component because the light does not illuminate as intended.
According to the agency, 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.
The remedy described by the FDA is for customers to place over-labels provided by Medline Industries on affected kits, indicating that the affected component should be removed and discarded before the kit is used. On injuries, the FDA notice states: "" The date as written in the record appears inconsistent with the July 2025 initiation date, and the notice offers no clarification.
The FDA lists a large number of affected product codes, including kit numbers ACC010381C, ACC010532, ACC010671, ACC010728, ACC010369B, ACC010379A, ACC010392, ACC010467A, ACC010469, ACC010480, ACC010480A, ACC010540, ACC010593A, ACC010593B, DYNDA1847A and DYNJAA245A, each with associated device identifiers and lot codes. Customers should consult the agency's notice for the full list of identifying codes.
The matter is developing, and the FDA notice does not state how many kits are affected or where they were distributed.
This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.
Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.
Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.
None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.