FirstAlerts

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.

By AI ReporterFirst reported Nov 21, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:47 p.m. ET

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The FDA's correction alert covering Medline convenience kits that contain the Flexicare BritePro Solo laryngoscope now lists a wider set of affected kit codes and lot numbers than earlier notices. According to the FDA, is updating the use instructions for kits containing the previously recalled component because the light does not illuminate as intended. The action was initiated on July 25, 2025, and The products are . The FDA states that if the light malfunctions, it may prevent effective illumination of the patient airway, and that use of affected product may cause serious adverse health consequences, including delay in treatment or requiring intubation using a different device and possibly death. The remedy given by the agency is to The full current list of identifying codes in the FDA notice, with device identifiers and lot numbers as recorded: ACC010381C — 10193489922127 (EA), 40193489922128 (CS) — lots 21LDA450, 21KDA979, 21JDB271, 21LDA608; ACC010532 — 10193489902358 (EA), 40193489902359 (CS) — lot 21FDA234; ACC010671 — 10195327351090 (EA), 40195327351091 (CS) — lot 23EDC536; ACC010728 — UDI/DI 10195327506544 (EA), 40195327506545 (CS) — lots 24EDC276, 23KDC368, 23KDB032; ACC010369B — 10193489777512 (EA) 40193489777513(CA) — lots 21DDA738, 21CDA614, 21BDA717; ACC010379A — 10193489777529 (EA) 40193489777520(CA) — lots 21BDB738, 21BDB493; ACC010392 — 10193489218053 (EA) 40193489218054(CA) — lots 24JDA206, 21HDB930, 21HDA284, 21EDB901, 21EDB869, 21EDB805; ACC010467A — 10193489834550 (EA) 40193489834551(CA) — lot 21EDA887; ACC010469 — 10193489414677 (EA) 40193489414678(CA) — lots 22BDA430, 21KDA741, 21CDA522, 21BDA753; ACC010480 — 10193489499933 (EA) 40193489499934(CA) — lots 21HDA876, 21FDB951, 21FDB019, 21EDA065, 21CDB872, 21BDB094; ACC010480A — 10195327009366 (EA) 40195327009367(CA) — lot 21JDB163; ACC010540 — 10193489977547 (EA) 40193489977548(CA) — lot 21IDC276; ACC010593A — 10195327168995 (EA) 40195327168996(CA) — lot 22EDB290; ACC010593B — 10195327195472 (EA) 40195327195473(CA) — lot 22FDB947; DYNDA1847A — 10193489481259 (EA) 40193489481250(CA) — lots 21FBG208, 21CBL507; and DYNJAA245A — 10193489804584 (EA) 40193489804585(CA) — lots 21LBV006, 21IBV349, 21HBT154, 21DBI703, 21CBN261. On injuries, the FDA notice states: "" The date as printed in the record predates the July 25, 2025 initiation date, and the notice does not explain the discrepancy.

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  1. Version 18 Aug 2026, 00:47current

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  2. Version 18 Aug 2026, 00:19current

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  3. Version 18 Aug 2026, 00:37current

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  4. Version 18 Aug 2026, 00:42current

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