10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Summary
The FDA issued a Class II for 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk by Becton Dickinson & Company. Reason: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes..
Details
Source
Device Recall
External ID
Z-1496-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
Lot/Code Info: Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.
Quantity Affected: 204,000 units
Reason for Recall
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Distribution
US Nationwide distribution in the states of California and Texas.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-27
Company
Franklin Lakes, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Company have FDA actions?
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1496-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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