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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

Becton Dickinson & Co.: BD BACTEC Plus Aerobic/F Culture Vials Recalled for Duplicate Barcodes

Agency Publication Date: October 12, 2023
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Summary

Becton Dickinson & Co. is recalling approximately 781,600 BD BACTEC Plus Aerobic/F Culture Vials due to a labeling error where duplicate barcode sequence numbers were printed on more than one vial. This defect involves Catalog Number 442023 across six specific lot numbers. Because these vials are used in automated blood culture systems to detect bacteria in patients, duplicate barcodes can lead to technical errors or patient sample confusion. If you are a healthcare provider using these vials, contact the manufacturer for specific instructions on how to handle affected inventory.

Risk

The duplicate barcodes can cause laboratory equipment to misidentify or fail to process blood culture samples correctly. This could lead to delays in diagnosing serious infections or potential errors in matching test results to the correct patient.

What You Should Do

  1. Immediately check your laboratory inventory for BD BACTEC Plus Aerobic/F Culture Vials with Catalog Number 442023.
  2. Verify if your vials belong to any of the following affected lot numbers: 3062843, 3062846, 3062849, 3062847, 3067489, or 3067488.
  3. Identify products using the UDI-DI code: 038290HXRPGWNNMN located on the packaging.
  4. Contact your healthcare provider or Becton Dickinson & Co. at their Sparks, Maryland facility for further instructions and to report any technical issues encountered with these vials.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD BACTEC Plus Aerobic/F Culture Vials
Model / REF:
Catalog Number 442023
UDI-DI: 038290HXRPGWNNMN
Lot Numbers:
3062843
3062846
3062849
3062847
3067489
3067488

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93097
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 781,600 vials
Distributed To: Nationwide

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.