Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
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Recall Number
Z-0872-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-31
Reported
2025-12-10
Distribution
US Nationwide distribution.
Code Info
Model: OER-Elite; UDI: 04953170404047; Serial #: All;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.