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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

Integra LifeSciences Corp.: AURORA Surgiscope System Recalled for Potential Sheath Damage and Bleeding Risk

Agency Publication Date: July 11, 2024
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Summary

Integra LifeSciences Corp. is recalling 14 units of the AURORA Surgiscope System, a sterile, single-use surgical device that includes a sheath, obturator, and imager. The recall was initiated because the sheath may be damaged, which could lead to complications during medical procedures. Consumers and healthcare providers should be aware that this defect can cause unintended tissue damage or internal bleeding along the surgical track.

Risk

The damaged sheath can cause physical trauma to surrounding body tissues or lead to a track hemorrhage (bleeding) during or after the surgical procedure. While no specific injuries were mentioned in the provided report, the potential for severe internal bleeding poses a significant health risk to patients.

What You Should Do

  1. Identify if you have the affected medical device by checking for AURORA Surgiscope System Model Number ASX9/130 with Lot Number 7336314 and UDI number 00850002332278.
  2. Immediately stop using any units from the affected lot (Lot No. 7336314) and sequester the product to prevent further use in surgical procedures.
  3. Contact your healthcare provider if you have recently undergone a procedure involving this device and have concerns about your recovery or symptoms of internal bleeding.
  4. Contact Integra LifeSciences Corp. at their Princeton, New Jersey headquarters for specific instructions on returning the defective units and obtaining replacements or a refund.
  5. For additional information or to report a problem, contact the FDA directly 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

Contact manufacturer for instructions.

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

Affected Products

Product: AURORA Surgiscope System
Model / REF:
ASX9/130
00850002332278
Lot Numbers:
7336314

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94804
Status: Active
Manufacturer: Integra LifeSciences Corp.
Sold By: Integra LifeSciences Corp.
Manufactured In: United States
Units Affected: 14 units
Distributed To: New York, Ohio, District of Columbia

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.