Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-1510-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPOT VISION SCREENER,W/CASE,PLUG4/UK, VS100S-4; f) SPOT VISION SCREENER,W/CASE,PLUG7/SA, VS100S-7; g) SPOT VISION SCREENER W/CASE, BRAZIL, VS100S-Z; h) SPOT VS POWER SUPPLY SET/PLUG2/EUR, 106364; i) SPOT VS POWER SUPPLY SET/PLUG4/UK, 106366; j) SPOT VS POWER SUPPLY SET/PLUG7/SA, 106368; for use during vision screening

Product Classification:

Class II

Date Initiated: March 26, 2024

Date Posted: April 17, 2024

Recall Number: Z-1510-2024

Event ID: 94295

Reason for Recall:

Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.

Status: Ongoing

Product Quantity: 3547 units

Code Information:

a) VS100-2, UDI/DI 732094224214; b) VS100-4, UDI/DI 732094224191; c) VS100-7, UDI/DI 732094224092; d) VS100S-2, UDI/DI 732094224177; e) VS100S-4, UDI/DI 732094224153; f) VS100S-7, UDI/DI 732094224085; g) VS100S-Z, UDI/DI 732094294217; h) 106364, UDI/DI 732094246964; i) 106366, UDI/DI 732094319927; j) 106368, UDI/DI 732094248692

Distribution Pattern:

Global, US: NY, IL

Voluntary or Mandated:

Voluntary: Firm initiated