FDA-Device2025-11-19Class IIPROCESSING DEFECT
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
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.
Intended for
Adults
Illnesses reported
None reported
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-0467-2026More Medline recalls
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- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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