FDA-Device2025-11-19Class II

Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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
1 unit
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, 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-0468-2026

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