Class 2 Device Recall BD LuerLok Tip Syringe

• Date Initiated by Firm: January 27, 2026
• Date Posted: March 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1496-2026
• Recall Event ID: 98314
• 510(K)Number: K980987
• Product Classification: Syringe, piston - Product Code FMF
• Product: 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
• Code Information: Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.
• FEI Number: 2243072
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Darren Walsh; 201-847-6800
• Manufacturer Reason for Recall: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
• FDA Determined Cause: Under Investigation by firm
• 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.
• Quantity in Commerce: 204,000 units
• Distribution: US Nationwide distribution in the states of California and Texas.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMF