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Recall Observatory FDA recall evidence

Device product

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

Z-0504-2026

October 14, 2025

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 97737
Status
Ongoing
Classification
Class II
Quantity
4180000 units
Official record key
device-enforcement:Z-0504-2026

Official wording

Reason: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

Code information: Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.