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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/Surgical Equipment

Technomed Europe: NEUROSIGN Stimulating Dissector Recalled for Discoloration and Contamination

Agency Publication Date: September 12, 2024
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Summary

Technomed Europe has recalled 71 units of the NEUROSIGN Disposable Stimulating Dissector (REF 5888-00) because a brown discoloration or unknown substance was discovered on the hinge area of the device. This surgical tool is used in neurological procedures, and the presence of foreign material on a disposable medical device poses a risk of infection or adverse patient reactions. The affected units include specific lot numbers 061158 and 061380 and were distributed in several U.S. states. Consumers and healthcare providers should stop using these specific lots immediately and contact the manufacturer for further instructions.

Risk

The presence of an unknown brown substance or discoloration on the device's hinge indicates potential contamination or material degradation. Using a contaminated surgical instrument can introduce foreign matter or pathogens into a patient during surgery, potentially leading to inflammation, infection, or other serious medical complications.

What You Should Do

  1. Identify your product by checking the packaging for NEUROSIGN Disposable Stimulating Dissector, Reference (REF) 5888-00.
  2. Verify the lot numbers and UDI on your device packaging; this recall specifically affects UDI/DI 08718375869659 with Lot Numbers 061158 or 061380.
  3. Immediately stop using any devices identified as part of the affected lots and quarantine them to ensure they are not used in surgical procedures.
  4. Contact Technomed Europe or your healthcare provider to discuss the next steps, return procedures, and how to obtain replacement products.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Medical Guidance

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

Affected Products

Product: NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Model / REF:
REF 5888-00
08718375869659
Lot Numbers:
061158
061380

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95188
Status: Active
Manufacturer: Technomed Europe
Sold By: Specialty medical distributors
Manufactured In: Netherlands
Units Affected: 71 units
Distributed To: Florida, California, Texas, Illinois, New York, Pennsylvania, Massachusetts

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.