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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

Medtronic Neuromodulation: SenSight Connector Plug Recalled for Incorrect Use By Date Labels

Agency Publication Date: October 18, 2023
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Summary

Medtronic Neuromodulation is recalling 65 units of the SenSight Connector Plug, Model Number B31061. This recall was initiated because the 'Use By Date' printed on the product label is incorrect, creating a discrepancy regarding the device's actual shelf life. Consumers and healthcare providers should check their inventory for the specific lot and GTIN numbers affected by this labeling error. This is a voluntary, firm-initiated recall of a small number of units distributed nationwide.

Risk

The discrepancy in the 'Use By Date' could lead to the use of a device beyond its validated shelf life, which may compromise the sterility or functional performance of the connector plug. While no injuries have been reported, using a device past its intended expiration date can increase the risk of infection or device failure during surgical procedures.

What You Should Do

  1. Locate your SenSight Connector Plug packaging and check for Model Number B31061.
  2. Verify if your product matches GTIN 00763000426576 and Lot Number 082U30721.
  3. Immediately stop using any affected connector plugs found with these specific identifiers.
  4. Contact your healthcare provider or Medtronic Neuromodulation at 7000 Central Ave Ne, Minneapolis, MN to arrange for the return of the affected units and to receive further instructions regarding replacements.
  5. For additional information or questions regarding this recall, 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

Return of affected units

How to: Medtronic is requesting the return of the small number of units affected by the labeling discrepancy. Contact the manufacturer for return logistics.

Affected Products

Product: SenSight Connector Plug
Model / REF:
B31061
UPC Codes:
00763000426576
Lot Numbers:
082U30721

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93083
Status: Active
Manufacturer: Medtronic Neuromodulation
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 65 devices
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.