FDAHealthOctober 14, 2025
Becton Dickinson & Company — BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
⚠️ BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 14, 2025
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.
What's affected?
- Product
- BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
- Lot code
- 5029670
Additional details
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4180000 units.
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