FDA Medical devices recall ·
BD Luer Tip Caps recall
- Recall number
- Z-0504-2026
- Date
- (initiated October 14, 2025)
- Company / brand
- Becton Dickinson & Co.
1 Becton Dr, Franklin Lakes, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4180000 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Why was it recalled?
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
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.
States: Alabama Arizona California Colorado Florida Georgia Hawaii Iowa Idaho Illinois Indiana Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0504-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.