Z-0504-2026 Class II Ongoing
FDA device recall Z-0504-2026 was initiated by Becton Dickinson & Company on October 14, 2025 and is designated Class II. Reason for recall: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. The recall status is ongoing. Affected quantity: 4180000 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- October 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4180000 units
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.
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.
Code Information
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;