—#212468

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

FDA product code: LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K191918
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

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.

Timeline

Recall initiated: 2025-02-12
Posted by FDA: 2025-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.