Data Foundry

Medical device recalls 2026

Brand Name: Welch Allyn — Class II medical device recall Z-1573-2026

Ongoing recall by Baxter Healthcare Corporation, reported 2026-03-25, distributed nationwide. Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce p

Recall numberZ-1573-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2026-02-18
Classified2026-03-18
Reported by FDA2026-03-25
DistributedNationwide (US)
Countries outside the USCO, IN
Quantity59
Reason classessoftware
UPC / GTIN / UDI-DI00732094212228, 00732094214154
Model numbers901029, VS100

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1573-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.