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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

BD Luer Tip Caps Recalled for Failed Biocompatibility Testing

Agency Publication Date: November 14, 2025
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Summary

Becton Dickinson & Company (BD) has recalled approximately 4,180,000 units of BD Luer Tip Caps because internal testing revealed that certain device trays failed routine biocompatibility safety standards. These caps, identified by catalog number 308341, are used to seal syringes and other medical devices. Consumers and healthcare providers should stop using the affected caps and contact the manufacturer to arrange for their return or replacement.

Risk

The failure of the device trays to pass biocompatibility testing means the materials may not be safe for contact with the human body or medical fluids. This could potentially lead to adverse reactions, irritation, or chemical exposure for patients when these caps are used in medical procedures.

What You Should Do

  1. The recalled products are BD Luer Tip Caps with Catalog Number 308341 and UDI-DI 50382903083416.
  2. Check your inventory for the following affected lot numbers: 5029670, 5034211, and 5041975.
  3. Stop using the recalled product immediately.
  4. Contact Becton Dickinson & Company or your medical supply distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Luer Tip Caps
Model / REF:
308341
Lot Numbers:
5029670
5034211
5041975
UDI:
50382903083416

Quantity affected: 4,180,000 units. UDI-DI is 50382903083416.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97737
Status: Active
Manufacturer: Becton Dickinson & Company
Sold By: Medical supply distributors; Hospital supply chains
Manufactured In: United States
Units Affected: 4180000 units
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.