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U.S. Department of Health and Human Services

Class 2 Device Recall Zebra Thermal Barcode Printer

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 Class 2 Device Recall Zebra Thermal Barcode Printersee related information
Date Initiated by FirmFebruary 12, 2025
Date PostedMarch 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1395-2025
Recall Event ID 96278
510(K)NumberK191918 
Product Classification Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
ProductZebra 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 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
FEI Number 1924669
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactErica Knox
800-255-6730
Manufacturer Reason
for Recall		Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 Commerce41
DistributionDomestic 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LRG
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