Recall Z-1395-2025— Remel, Inc

Name: FDA recall Z-1395-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-12

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2025-02-12. It names one FDA 510(k) clearance: K191918. Product: Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ. Reason: Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-02-12
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K191918 — Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific·cleared 2019-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

Reason for recall

Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

Data sourced from openFDA. This site is unofficial and independent of the FDA.