The Recall Desk
CriticalFDA (Devices)·Z-2566-2025·Announced 2025-10-01

Intubation trays recalled after laryngoscope handle lights failed to illuminate

Medline is recalling 2,520 intubation and airway kits containing Flexicare BritePro Solo fiber optic laryngoscope handles because the light may fail to illuminate as intended.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

Medline Industries is recalling specific items and lots of medical convenience kits that contain Flexicare BritePro Solo Fiber Optic Laryngoscope Handles, because the handle light can fail to illuminate as intended.

Twelve kit configurations are affected, including Adult Intubation Tray (ACC010369B), Adult ICU Intubation Tray (ACC010379A), Intubation Tray (ACC010392), Intubation Kit (ACC010467A), Adult Airway Tray (ACC010469), Tray 2 Intubation Drawer (ACC010480 and ACC010480A), Adult Intubation (ACC010540), Difficult Airway Tray #1 (ACC010593A and ACC010593B), Intubation Tray (DYNDA1847A) and Intubation Tray Adult (DYNJAA245A). The recall covers 2,520 units distributed to Alabama, California, Delaware, Oregon, Tennessee and Texas. The FDA has classified the recall as Class I.

Hospitals and emergency departments holding the listed kit numbers and lots should identify affected stock and follow Medline's instructions, ensuring an alternative working laryngoscope is available where these kits are stocked for airway management.

The recalled product

Product
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC01
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Airway management
Hazard
Affected units
2,520

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. ACC010369B
  • UDI/DI 10193489777512 (EA) 40193489777513(CA)
  • Lot Numbers: 2. ACC010379A
  • 10193489777529 (EA) 40193489777520(CA)
  • Lot Numbers: 3. ACC010392
  • 10193489218053 (EA) 40193489218054(CA)
  • Lot Numbers: 4. ACC010467A
  • 10193489834550 (EA) 40193489834551(CA)
  • Lot Numbers: 5. ACC010469
  • 10193489414677 (EA) 40193489414678(CA)
  • Lot Numbers: 6. ACC010480
  • 10193489499933 (EA) 40193489499934(CA)
  • Lot Numbers: 7. ACC010480A
  • 10195327009366 (EA) 40195327009367(CA)
  • Lot Numbers: 8. ACC010540
  • 10193489977547 (EA) 40193489977548(CA)
  • Lot Numbers: 9. ACC010593A
  • 10195327168995 (EA) 40195327168996(CA)
  • Lot Numbers: 10. ACC010593B
  • 10195327195472 (EA) 40195327195473(CA)

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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