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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

ReNew Microscissor Tips Recalled for Potential Heat Shrink Detachment

Agency Publication Date: December 10, 2024
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Summary

Microline Surgical, Inc. has recalled approximately 200 units of its ReNew Microscissor Tip (Disposable) because a component called the heat shrink can break off from the device. This recall involves catalog number 3122 specifically from lot number 00172110. While no injuries have been reported, the failure was identified to occur at a rate of 2%. If you use these tips, you should immediately check your inventory and contact the manufacturer for a replacement or return.

Risk

The heat shrink on the microscissor tip can break off during use, which could result in a piece of the device being left inside a patient's body during surgery or cause the scissors to fail during a procedure. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects disposable ReNew Microscissor Tips with Microline Catalog number 3122 and lot number 00172110 (UDI/DI 811099010036).
  2. Stop using the recalled device immediately and remove any affected units from your surgical inventory.
  3. Contact Microline Surgical, Inc. or your specialty medical distributor to arrange for the return, replacement, or correction of the affected products.
  4. Call 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
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ReNew Microscissor Tip (Disposable)
Model / REF:
3122
Lot Numbers:
00172110
UDI:
811099010036

Recall #: Z-0663-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95734
Status: Active
Manufacturer: Microline Surgical, Inc.
Sold By: Specialty medical distributors
Manufactured In: United States
Units Affected: 200 units
Distributed To: Oklahoma

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.