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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

Oxoid Levofloxacin Susceptibility Discs Recalled for Mislabeling

Agency Publication Date: February 4, 2025
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Summary

Oxoid Limited is recalling 1,406 units of its Levofloxacin Susceptibility Discs (Lev5) because the packaging may actually contain Norfloxacin discs. These discs are laboratory tools used by healthcare professionals to determine which antibiotics will effectively treat a patient's bacterial infection. No injuries or incidents have been reported in connection with this mislabeling.

Risk

The use of mislabeled discs can lead to incorrect laboratory test results. This could cause a patient to be treated with the wrong antibiotic or an ineffective medication for their specific infection.

What You Should Do

  1. This recall affects Oxoid Levofloxacin Susceptibility Discs (50 discs, REF CT1587B) identified by lot number 6142394 and UDI 5032384079629.
  2. Stop using the recalled laboratory products immediately.
  3. Contact Oxoid Limited or your distributor to arrange for a return, replacement, or correction of the affected discs.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information or to report a problem.

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: Oxoid Lev5 Susceptibility Discs Levofloxacin 5 ug (50 discs)
Variants: IVD, CE 2797
Model / REF:
CT1587B
Lot Numbers:
6142394
UDI:
5032384079629

Packaging for Levofloxacin may contain Norfloxacin Antimicrobial Susceptibility discs.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96113
Status: Active
Manufacturer: Oxoid Limited
Sold By: Laboratory suppliers; Medical distributors
Manufactured In: United Kingdom
Units Affected: 1406 units
Distributed To: Virginia, California, Nebraska, Massachusetts, Florida, New Hampshire, Washington

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.