FDA Enforcement Class II Ongoing

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

Recall: Z-2260-2026 · Reported June 3, 2026

Enforcement

Recall Number
Z-2260-2026
Event ID
98866
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Medline Industries, LP
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
June 3, 2026
Initiation Date
April 10, 2026
Classification Date
May 28, 2026
Address
3 Lakes Dr, Northfield, IL, 60093-2753, United States

Description

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

Reason

Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.

Code Info

UDI/DI 10198459151569 (each), 40198459151560 (case), Lot Numbers: 26BMC538

Distribution

US Nationwide distribution in the states of California.

Quantity

8 kits