Reported Mar 25, 2026 · Ongoing

Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software…

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Brand NameWelch Allyn, Inc
  • Product NameWelch Allyn Spot Vision
  • Screener VS100 Model/Catalog NumberVS100
  • Software VersionSoftware version 3.2.0.1
  • Product DescriptionWelch Allyn Spot Vision Screener VS100
  • FDA product code nameRefractometer, ophthalmic One unit per package
Lot codes and dates
  • Lot Code"
  • Product CodeHKO "
  • Version or Model901029 "
  • Catalog NumberVS100 "
  • Company NameWELCH ALLYN, INC. "
  • Primary DI Number00732094214154 "
  • Packaging DI Number00732094212228 "
  • Device DescriptionVS100 UDI BASE UNIT "
  • Software version3.2.0.1 "
  • Serial NumbersRefer to attached Affected Product Table
Amount recalled
59

Where it was sold

Why it was recalled

Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:28 PM UTC

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