Recall Z-0504-2026 ยท KYW Container, Liquid Medication, Graduated
Becton Dickinson & Company
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
| Date | Nov 14, 2025 (initiated Oct 14, 2025) |
| Status | Open, Classified |
| Reason | BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. |
| Root cause | Under Investigation by firm |
| Action | On October 14, 2025, URGENT: MEDICAL DEVICE REMOVAL letters were sent to distributors and customers. Please Take the Following Actions: 1. Cease use and destroy any unused affected product according to your facilities regulations. BD will provide credit for all product destroyed. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. 3. Complete the attached Distributor Response Form and return |
| Quantity | 4180000 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.