FDA recall Z-0504-2026

Becton Dickinson & Company · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-10-14
Report date
2025-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2026