—#218229

Product

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

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K980987
Affected lot / code info: Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: US Nationwide distribution in the states of California and Texas.

Timeline

Recall initiated: 2026-01-27
Posted by FDA: 2026-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.