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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.: Crescent Knife Recalled Due to Incorrect Blade Orientation

Agency Publication Date: January 4, 2024
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Summary

Beaver Visitec International, Inc. has recalled 1,980 units of the Conventional Knife Crescent (2.5mm, 55 degrees bevel up) because one lot was found to contain bevel-down blades instead of the intended bevel-up design. This specific product, identified by Part Number 373807, is a surgical instrument used in medical procedures. The error in blade orientation could lead to surgical complications if not identified prior to use. Consumers should check their inventory for Lot Number 6054027 to see if they are affected.

Risk

The use of a bevel-down blade when a surgeon expects a bevel-up blade can lead to unintended tissue damage, improper surgical planes, or complications during delicate ophthalmic procedures. This mechanical defect poses a risk of surgical error and potential injury to the patient during use.

What You Should Do

  1. Immediately check your medical inventory for the Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807.
  2. Verify if your product belongs to the affected Lot Number 6054027 with UDI-DI 30886158000571.
  3. If you identify an affected knife, stop using it immediately and quarantine the product to prevent further use in surgical procedures.
  4. Contact your healthcare provider or Beaver Visitec International, Inc. for specific instructions on returning the affected units and obtaining a replacement or potential refund.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Product quarantine and replacement

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

Affected Products

Product: Conventional Knife Crescent 2.5mm, 55 degrees bevel up (Part Number 373807)
Model / REF:
373807
Z-0632-2024
UPC Codes:
30886158000571
Lot Numbers:
6054027

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93547
Status: Active
Manufacturer: Beaver Visitec International, Inc.
Sold By: International medical distributors
Manufactured In: United States
Units Affected: 1980 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 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.