FDA Enforcement Class II Ongoing

10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

Recall: Z-1496-2026 · Reported March 18, 2026

Enforcement

Recall Number
Z-1496-2026
Event ID
98314
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Becton Dickinson & Company
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
E-Mail
Report Date
March 18, 2026
Initiation Date
January 27, 2026
Classification Date
March 6, 2026
Address
1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

Description

10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

Reason

During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

Code Info

Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.

Distribution

US Nationwide distribution in the states of California and Texas.

Quantity

204,000 units