Recalls / —

—#216459

Product

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

FDA product code

KYW — Container, Liquid Medication, Graduated

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 5. Report any complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: productcomplaints@bd.com

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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.

Timeline

Recall initiated

2025-10-14

Posted by FDA

2025-11-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #216459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.