Class IIReported 2026-03-25

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

Recalled by Baxter Healthcare Corporation

Reason for Recall

Display screen may unintentionally flicker due to a software issue

Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.

Recall Number

Z-1573-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-02-18

Reported

2026-03-25

Distribution

Worldwide - 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.

Code Info

Lot Code: " Product Code: HKO " Version or Model: 901029 " Catalog Number: VS100 " Company Name: WELCH ALLYN, INC. " Primary DI Number: 00732094214154 " Packaging DI Number: 00732094212228 " Device Description: VS100 UDI BASE UNIT " Software version: 3.2.0.1 " Serial Numbers: Refer to attached Affected Product Table

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.