FDA Device Recall Z-2566-2025

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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.

Lot / serial / GTIN: 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:

Quantity: 2520 units

Reason for recall

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.

Recall record

Recall number: Z-2566-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: US distribution to: AL, CA, DE, OR, TN, TX
Recall initiated: 2025-07-25
Classified by FDA Center: 2025-09-19
FDA published: 2025-10-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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