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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

Beaver Visitec International, Inc.: Xstar Kojo Safety Slit Knife Recalled Due to Incorrect Blade Orientation

Agency Publication Date: January 4, 2024
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Summary

Beaver Visitec International, Inc. has recalled 2,160 units of the Xstar Kojo Safety Slit Knife, 2.5mm 45° Bevel Up (Part Number 373025). The recall was initiated because some packages incorrectly contain a bevel down blade instead of the intended bevel up blade. Using a blade with an incorrect orientation during surgical procedures could lead to unintended surgical outcomes or injury to the patient.

Risk

The device contains a blade oriented in the opposite direction (bevel down) than what is labeled on the packaging (bevel up). This defect can cause the surgeon to make an incorrect incision or damage tissue during medical procedures because the cutting edge is not positioned as expected.

What You Should Do

  1. Identify your product by checking the packaging for Xstar Kojo Safety Slit Knife, 2.5mm 45° Bevel Up, Part Number 373025.
  2. Locate the Lot Number and UDI-DI on the label to see if it matches the affected stock: Lot Number 6049877 and UDI-DI 30886158000373.
  3. Immediately stop using any slit knives from the affected lot to prevent surgical errors or patient injury.
  4. Contact Beaver Visitec International, Inc. or your healthcare provider for specific instructions on returning the product and receiving a replacement or refund.
  5. For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer Notification

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

Affected Products

Product: Xstar Kojo Safety Slit Knife, 2.5mm 45° Bevel Up
Model / REF:
373025
Z-0633-2024
UPC Codes:
30886158000373
Lot Numbers:
6049877

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93555
Status: Active
Manufacturer: Beaver Visitec International, Inc.
Sold By: International distribution to Japan
Manufactured In: United States
Units Affected: 2160 units
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 · 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.