Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or… recallZ-1395-2025 · Remel, Inc · initiated Feb 12, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number: Z-1395-2025
Status: Open, Classified
Initiated by the company: Feb 12, 2025
Posted by the FDA: Mar 19, 2025
Recalling firm: Remel, Inc
Quantity: 41
Product code: LRG
FDA submissions: K191918
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 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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Thermo Scientific™ Sensititre™ ARIS HiQ™ System V4000
Trek Diagnostic Systems Limited · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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