FDA recall, , Moderate risk
Welch Allyn Spot Vision Screener VS100
The Welch Allyn Spot Vision Screener VS100 may have a flickering display that can cause seizures in susceptible people.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois, began a recall of the Welch Allyn Spot Vision Screener VS100 on February 18, 2026, because the display screen may unintentionally flicker due to a software issue, and exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
The recall was added to the FDA's Enforcement Report and classified on March 18, 2026, and in FDA's weekly enforcement report on March 25, 2026. The product, a refractometer, ophthalmic, with software version 3.2.0.1, was distributed worldwide, including US nationwide distribution in the states of AZ, CO, IL, IN, KS, MA, NE, NJ, NM, NY, PA, SC, TX, VA and the countries of Colombia and India.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Welch Allyn Spot Vision Screener VS100
- Lot code
- 901029
From the FDA notice
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Arizona, Colorado, Illinois, Indiana, Kansas, Massachusetts, Nebraska, New Jersey, New Mexico, New York, Pennsylvania, South Carolina, Texas, Virginia and the countries of Colombia and India.
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98439
- Recall number
- Z-1573-2026
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
