BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Summary
The FDA issued a Class II for BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; by Becton Dickinson & Company. Reason: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing..
Details
Source
Device Recall
External ID
Z-0504-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Lot/Code Info: Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
Quantity Affected: 4180000 units
Reason for Recall
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-14
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 222 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-0504-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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