Device recall

Z-1573-2026: Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener…

FDA device recall · Class II · Baxter Healthcare Corporation

Key facts

Recall number (Z-number) Z-1573-2026
Recall event 98439
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
Product code HKO
Recalling firm Baxter Healthcare Corporation
Recall class Class II
Status Open, Classified
FEI number 1417572

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)