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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Numbers | Z-1395-2025 |
| Risk Class | Class 2 |
| Recall Qty | 41 |
| Classification Date | 2025-03-19 |
| Recall Link | Search FDA Site |
| Notes/Alerts | Zebra printers potentially used with Thermo Scientific Aris HiQ Systems |
| Recall Reason | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. |
DEVICE
| Manufacturer | Zebra |
|---|---|
| Model Names | Thermal Barcode Printer GX430t |
| Model Numbers | 808101-001 |
| Part/Item/Catalog/ REF/Product Number | |
| Device 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 |
| Serial Number(s) | This page explains the issue in more detail including a method of looking up the serial number of the affected devices: https://www.zebra.com/us/en/power-supply-recall.html |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
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
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to Zebra. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
