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All product recalls associated with Ivena International Pte. Ltd., of Singapore.
Total Recalls
1000
Past Year
276
Class I (Serious)
242
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
This recall involves Ivena 20" teak shower benches. The benches are made of light brown teak with padding on the feet. The seat and bottom shelf have a row of wood paneling. Item number 1049998 and UPC 8886474018015 are printed on the exterior packaging. The bench has a label that says, "100% wood from well-managed forests."
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.