CLASS II ONGOING Device recall · Reported 25 Mar 2026 · FDA Enforcement Report

Welch Allyn Spot Vision Screener VS100 recalled by Baxter Healthcare

Baxter Healthcare is recalling Welch Allyn Spot Vision Screener VS100, distributed nationwide in the US. The recall was initiated on 18 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled59

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1573-2026
FDA event ID: 98439
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 18 Feb 2026
FDA classified: 18 Mar 2026
Reported: 25 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

18 Feb 2026	Recall initiated by company
18 Mar 2026	Classified by FDA	+28 days
25 Mar 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona Colorado Illinois Indiana Kansas Massachusetts Nebraska New Jersey New Mexico New York Pennsylvania South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots 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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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