Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an op...
FDA Device Recall #Z-1395-2025 — Class II — February 12, 2025
Recall Summary
| Recall Number | Z-1395-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 12, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Remel, Inc |
| Location | Lenexa, KS |
| Product Type | Devices |
| Quantity | 41 |
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
Reason for Recall
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
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.
Lot / 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
Other Recalls from Remel, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1474-2026 | Class II | Campy CVA Medium 100/PK, R01272 | Feb 5, 2026 |
| Z-0585-2026 | Class II | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 ... | Nov 12, 2025 |
| Z-2224-2025 | Class II | Strep Selective II Agar, Product Number R01859 | Jul 11, 2025 |
| Z-2223-2025 | Class II | Blood Agar,5% Sheep Blood 100/PK, Product Numbe... | Jul 11, 2025 |
| Z-2225-2025 | Class II | Blood/EMB, Levine 100/PK, Product Number R02041 | Jul 11, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.