BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
FDA Recall #Z-0504-2026 — Class II — October 14, 2025
Product Description
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Reason for Recall
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Recalling Firm
Becton Dickinson & Company — Franklin Lakes, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4180000 units
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.
Code Information
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated