CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
Zebra Thermal Barcode Printer GX430t recalled by Remel
Remel is recalling Zebra Thermal Barcode Printer GX430t, distributed nationwide in the US. The recall was initiated on 12 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1395-2025
- FDA event ID
- 96278
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2025
- FDA classified
- 19 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Feb 2025 | Recall initiated by company | |
| 19 Mar 2025 | Classified by FDA | +35 days |
| 26 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIndianaKansasKentuckyMarylandMichiganNebraskaNew YorkOhioPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Is Zebra Thermal Barcode Printer GX430t recalled?
Yes. Remel recalled Zebra Thermal Barcode Printer GX430t on 12 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1395-2025.
Why was it recalled?
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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