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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

Vortex Surgical Laser Probes Recalled for Cannula Passage Difficulty

Agency Publication Date: December 30, 2025
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Summary

Vortex Surgical Inc. is voluntarily recalling 221 units of the 25ga Illuminated Flex-Tip Laser Probe (Catalog Number VS0135.25). This recall was initiated because some probes in the affected lot do not pass through a 25-gauge cannula smoothly. If this mechanical resistance occurs during a procedure, it could result in surgical delays or complications.

Risk

The probes may fail to pass through the surgical cannula smoothly, potentially interfering with precision during delicate eye surgeries. No injuries have been reported to date.

What You Should Do

  1. This recall affects the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe (Catalog Number VS0135.25) from Lot Number 2509040.
  2. Check your surgical supplies for Box UDI (01)00810123483617(17)281001(10)2509040 or Pouch UDI (01)00810123483549(17)281001(10)2509040 to determine if your inventory is affected.
  3. Stop using the recalled device. Contact Vortex Surgical Inc. or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) 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: Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe
Model / REF:
VS0135.25
Lot Numbers:
2509040 (Exp 10/01/2028)
UDI:
00810123483617
00810123483549

UDI Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98032
Status: Active
Manufacturer: Vortex Surgical Inc.
Sold By: Medical distributors; Surgical centers; Hospitals
Manufactured In: United States
Units Affected: 221 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.