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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

MST ArcDUO Ophthalmic Knives Recalled for Potential Residue Contamination

Agency Publication Date: October 29, 2025
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Summary

MicroSurgical Technology Inc is recalling 8 units of the MST ArcDUO 9mm single-use, sterile ophthalmic knife (REF: ARC-0002). The recall was initiated because the accompanying suction set (Part: 48-1000-01) contains springs contaminated with an unidentified residue. While the suction set does not come into direct contact with the patient, the residue could potentially cause eye irritation during or after a procedure.

Risk

The unidentified residue on the suction set springs may lead to eye irritation or inflammation for patients undergoing surgery with this device. No injuries or specific incidents have been reported to date.

What You Should Do

  1. This recall involves MST ArcDUO 9mm single-use, sterile ophthalmic knives (REF: ARC-0002) used in conjunction with Suction Set Part: 48-1000-01.
  2. Check your surgical inventory for UDI 00844685014316 and lot numbers 207552 or 208238 to identify affected products.
  3. Stop using the recalled device immediately to prevent potential patient irritation.
  4. Contact MicroSurgical Technology Inc or your medical supply distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

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: MST ArcDUO 9mm Ophthalmic Knife
Variants: Single-use, Sterile
Model / REF:
ARC-0002
Lot Numbers:
207552
208238
UDI:
00844685014316

Recall #: Z-0411-2026. Used with Suction Set, Part: 48-1000-01.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97470
Status: Active
Manufacturer: MicroSurgical Technology Inc
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 8
Distributed To: Georgia

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.