Z-0467-2026 Class II Ongoing
FDA device recall Z-0467-2026 was initiated by Medline Industries, LP on October 1, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 4226 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- October 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4226 units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
UDI/DI 20193489189688 (each), 10193489189681 (case), All Lots