Recall Z-1573-2026 ยท HKO Refractometer, Ophthalmic
Baxter Healthcare Corporation
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
| Date | Mar 18, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals. |
| Root cause | Device Design |
| Action | On 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.