FDA Medical devices recall ·
Medline medical convenience kits labeled as: 1… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2566-2025
- Date
- (initiated July 25, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 2520 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A.
Why was it recalled?
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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), Lot Numbers: 11. DYNDA1847A; 10193489481259 (EA) 40193489481250(CA), Lot Numbers: 12. DYNJAA245A. 10193489804584 (EA) 40193489804585(CA), Lot Numbers:
Distribution
US distribution to: AL, CA, DE, OR, TN, TX
States: Alabama California Delaware Oregon Tennessee Texas
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2566-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.