FDAClass IIMarch 25, 2026

Brand Name: Welch Allyn recall: Software Issue

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

Why was Brand Name: Welch Allyn recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version…
Recalling firm
Baxter Healthcare Corporation
Quantity
59
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.
Recall date
March 25, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls