FDA Correction Alert on Medline Kits Now Lists 16 Kit Codes Containing Flexicare BritePro Solo
The agency's notice, in its most serious recall class, now covers a longer list of Medline convenience kit codes and lot numbers whose laryngoscope component may fail to illuminate.
4 reports on this incident · first at Aug 7, 2026, 8:19 p.m. ET
Earlier reports
Aug 7, 2026, 8:42 p.m. ET
FDA Notice Lists Medline Kit Correction in Most Serious Recall Class
The FDA's notice on Medline Industries, LP's correction to medical convenience kits containing the Flexicare BritePro Solo now carries the classification the agency describes this way: "The FDA has identified this recall as the most serious type." 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: "As of August 8, 2005, Medline Industries has not reported any serious injuries or deaths associated with this issue." 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.
Aug 7, 2026, 8:37 p.m. ET
FDA Notice on Recalled Medline Kits Records No Serious Injuries or Deaths
The FDA's correction alert covering Medline medical convenience kits containing the Flexicare BritePro Solo laryngoscope states that Medline Industries, LP "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.
Aug 7, 2026, 8:19 p.m. ETFirst report
FDA Flags Medline Kits Containing Flexicare BritePro Solo Laryngoscope in Most Serious Recall Class
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, Medline Industries, LP 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.
The FDA has identified this recall as the most serious type. 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: "As of August 8, 2005, Medline Industries has not reported any serious injuries or deaths associated with this issue." 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.
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First published.
- Version 18 Aug 2026, 00:19current
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- Version 18 Aug 2026, 00:42current
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