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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn, Inc.

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 Class 2 Device Recall Welch Allyn, Inc.see related information
Date Initiated by FirmFebruary 18, 2026
Date PostedMarch 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1573-2026
Recall Event ID 98439
Product Classification Refractometer, ophthalmic - Product Code HKO
ProductBrand 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 Information 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
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
1-800-4229837
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn February 18, 2026, the firm notified consignees via Urgent Medical Device Recall letters. Users were instructed to immediately locate, isolate, and stop using the listed affected products. Customers should contact Baxter Technical Support to arrange for the return and correction of their impacted device. Baxter may provide a loaner device upon request while your device is being upgraded and serviced. Distributors should return unopened products in inventory for credit. If affected product was further distributed, the distributor should conduct a consumer-level recall.
Quantity in Commerce59
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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