Z-1395-2025Class II

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional...

Name: Z-1395-2025 Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional...
Creator: Remel, Inc
Published: 2025-02-12
License: https://open.fda.gov/license/

Remel Inc / initiated 2025-02-12 / Open, Classified / root cause: manufacturing process

FDA source

Remel, Inc began a recall of 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 on 2025-02-12. FDA classified it as Class II and gives the reason as "Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1395-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-12
Posted: 2025-03-19
Recalling firm: Remel Inc
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
Product code: LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Reason for recall: Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On February 12, 2025, the firm notified affected customers through Urgent Medical Device Recall letters. Customers were instructed to check the manufacturing label on the back or bottom of their printer to confirm if it was one of the affected printers. If the label lists Zebra Technologies as the manufacturer, please use the validation form on the Zebra website to fully validate if your power supply is affected. More information can be found on the Zebra website: https://www.zebra.com/us/en/power-supply-recall.html
Quantity in commerce: 41
Distribution: Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution to Canada and the Bahamas.
Product codes and lots: UDI-DI 05032384545872. Detailed list of affected Zebra printer models: https://www.zebra.com/us/en/power-supply-recall.html Please check the manufacturing label found either on the back or bottom of your printer. If the label lists Zebra Technologies as the manufacturer, please use the validation form on the Zebra website to fully validate if your power supply is affected: https://connect.zebra.com/safeguard

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-19

Product code LRG

K191918Class IIThermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific / cleared 2019-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)