Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Recall NumberZ-1618-2026ClassificationClass IIIStatusOngoingCategorydeviceInitiated2025-09-05Reported2026-04-01DistributionUS Nationwide distribution.Code InfoModel No. 989605326521, 989605440872, 989605440871; UDI: (01)00884838067714(21)02Q19C, (01)00884838067714(21)02VF0G, (01)00884838067714(21)02DNKX, (01)00884838067714(21)02BXT7, (01)00884838067714(21)02TWD3, (01)00884838067714(21)02RRQX, (01)00884838067714(21)02HD9F; Serial No. 02V8MV, 02Q19C, 02DNGH, 02TWL6, 02P2LF, 031XK6, 02VF0G, 02HJ9Q, 02DNKX, 02BXT7, 02VHQZ, 02TWD3, 02NDCL, 02CBD4, 02RRQX, 02KWQ9, 02HD9F.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.