FDA-Device2025-11-19Class II

Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device

Medline Industries, LP
Hazard

Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

Sold states
US Nationwide distribution.
Affected count
4226 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2026

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