FDA-Device2025-11-19Class IIPROCESSING DEFECT
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
58,499 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0469-2026More Medline recalls
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