Z-1496-2026Class II

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

Name: Z-1496-2026 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case
Creator: Becton Dickinson & Company
Published: 2026-01-27
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2026-01-27 / Open, Classified / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case on 2026-01-27. FDA classified it as Class II and gives the reason as "During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1496-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-27
Posted: 2026-03-06
Recalling firm: Becton Dickinson & Co
Product: 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Product code: FMF Syringe, Piston
Reason for recall: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Root cause tag: packaging
FDA root 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.
Product codes and lots: Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1496-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1496-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-06

Product code FMF

K980987Class IIBecton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1998-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)