FDAClass IINovember 26, 2025

BD Luer Tip Caps recall

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

Why was BD Luer Tip Caps recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Recalling firm
Becton Dickinson & Company
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.
Recall date
November 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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