← FDA ENFORCEMENT
Z-1573-2026Class II

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Device
Status
Ongoing
Report date
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.
Firm state
IL
Product quantity
59
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot 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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.