FDA-Device2025-11-19Class II

Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm 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
65 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm 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-0472-2026

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