FDA recall Z-0467-2026

Medline Industries, LP · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-10-01
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

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