FDA-Device2025-11-19Class IIPROCESSING DEFECT
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Hazard
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution and OUS (foreign) to country of: Canada.
Affected count
22, 476 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2026Want us to check the next one for you?
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