Becton Dickinson & Company: Medical Device Recall in 2025 - (Recall #: Z-0504-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 14, 2025

Date Posted: November 26, 2025

Recall Number: Z-0504-2026

Event ID: 97737

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4180000 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated