Remel, Inc recalls Zebra Thermal Barcode Printer GX430t
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Nonconforming Material/Component
Reason for recall
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ systemYV4000-VZUDI-DI 05032384545872.Model https
What the firm is doing
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
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1395-2025
- FDA 510(k) clearance · K191918The device's official FDA premarket clearance record
- FDA device classification · LRGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 866.1640The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Remel, IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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