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Open, Classified

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

FDA Recall Z-1395-2025 · Posted 2025-03-19

Recalling FirmRemel, Inc
Recall StatusOpen, Classified
Product CodeLRG
Date Initiated2025-02-12
Product Quantity41

Reason for Recall

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

Firm 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

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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