FDA Recall Open, Classified

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

Recall: Z-1496-2026 · Initiated January 27, 2026

Recall

Recall Number
Z-1496-2026
Event Number
98314
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
FMF
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
January 27, 2026
Posted
March 6, 2026
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

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.

Action

Becton Dickinson notified consignees on about 01/27/2026 via emailed URGENT: Medical Device Recall (Correction) letter. Consignees were instructed to visually verify that the correct syringe is selected for the intended clinical application prior to use and that it forms a secure connection, destroy any luer slip syringes found in inventory, circulate the notification to all personnel who need to be aware or to any organization where the potentially affected products have been transferred, and complete and return the provided Customer Response Form. Distributors and kit manufactures were instructed to identify all customers within their distribution network that purchased any affected product and provide a copy of the customer letter to all customers to advise them of this field action notification on BD s behalf. Becton Dickinson is investigating the root cause and will take corrective actions to prevent recurrence of the issue as well as will provide replacement for all discarded inventory.

Distribution

US Nationwide distribution in the states of California and Texas.

Quantity

204,000 units