Medline intubation kit laryngoscope handles recalled for light illumination failure
Medline is recalling specific intubation kits with Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to light illumination failure. The handles may not illuminate properly, potentially affecting visibility during intubation procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall, which requires a minimum severity score of 4 per the stated classification rule. The documented light illumination failure on a critical airway management device presents a direct patient safety risk during intubation procedures.
Plain-English summary
Medline Industries, LP is recalling specific batches of intubation kits and trays containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. The recall affects 12 different product configurations totaling approximately 2,520 units distributed to healthcare facilities in Alabama, California, Delaware, Oregon, Tennessee, and Texas.
The laryngoscope handles have been found to fail to illuminate as intended. This malfunction affects the proper functioning of the device for its intended use in intubation procedures.
Healthcare facilities that received these products should immediately discontinue use and contact Medline Industries for replacement or return instructions. For specific lot numbers and product codes, refer to FDA recall Z-2566-2025.
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
- Hazard
- device-malfunction
- light-failure
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:
- AL
- CA
- DE
- OR
- TN
- TX
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