Data Foundry

Medical device recalls 2025

Zebra Thermal Barcode Printer GX430t — Class II medical device recall Z-1395-2025

Ongoing recall by Remel, Inc, reported 2025-03-26, distributed in AL, AZ, CA, FL, GA, IN, KS, KY…. Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

Recall numberZ-1395-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemel, Inc, Lenexa, KS, United States
Recall initiated2025-02-12
Classified2025-03-19
Reported by FDA2025-03-26
DistributedAL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI
Countries outside the USBS, CA
Quantity41
Reason classesdevice malfunction
UPC / GTIN / UDI-DI05032384545872
Model numbers1000, 2000

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 for recall

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

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-1395-2025. 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.