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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/Diagnostic Equipment

Welch Allyn Spot Vision Screener VS100 Recalled for Display Flickering

Agency Publication Date: March 18, 2026
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Summary

Baxter Healthcare Corporation is recalling 59 units of the Welch Allyn Spot Vision Screener VS100 (Software version 3.2.0.1) because the display screen may unintentionally flicker. This software-related issue can cause the screen to strobe or flash during use. The device is a handheld, portable tool used by healthcare professionals to screen for vision issues in patients. Baxter initiated the recall on February 18, 2026, through notification letters to affected customers in several U.S. states and internationally.

Risk

Exposure to flickering or strobing lights can trigger photosensitive seizure activity in susceptible individuals, potentially leading to serious health complications during a vision screening.

What You Should Do

  1. Identify if you have the affected Welch Allyn Spot Vision Screener VS100 by checking the catalog number 'VS100' and software version '3.2.0.1'.
  2. Check the serial number on your device label and compare it against the list of affected units. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Welch Allyn Spot Vision Screener VS100
Variants: Software version 3.2.0.1
Model / REF:
VS100
901029
Serial Numbers:
Refer to attached Affected Product Table
Lot Numbers:
HKO
UDI:
00732094214154
00732094212228

FDA product code name: Refractometer, ophthalmic; UDI BASE UNIT; Product Code: HKO

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98439
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Authorized medical distributors; Direct sales
Manufactured In: United States
Units Affected: 59
Distributed To: Arizona, Colorado, Illinois, Indiana, Kansas, Massachusetts, Nebraska, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Texas, Virginia

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.