Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 4...

FDA Device Recall #Z-0477-2026 — Class II — October 1, 2025

Recall Summary

Recall Number Z-0477-2026
Classification Class II — Moderate risk
Date Initiated October 1, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries, LP
Location Northfield, IL
Product Type Devices
Quantity 9,547 units

Product Description

Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10 Generator 44 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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.

Lot / Code Information

UDI/DI 10888277719439 (each), 20888277719436 (case), All Lots

Other Recalls from Medline Industries, LP

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Z-1650-2026 Class II Puracol and Puracol Plus Collagen Wound Dressin... Feb 10, 2026
Z-1562-2026 Class II Medline Kits containing Cardinal Health s Aqua-... Jan 30, 2026
Z-1563-2026 Class II Medline Medcrest Surgical Gowns: MDTGXC4J5XL... Jan 28, 2026
Z-1564-2026 Class II Medline Surgical Drapes: MDTBTCS6070GN DBD-DRA... Jan 28, 2026
Z-1464-2026 Class II Medline Kits containing Tego Connectors Medlin... Jan 8, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.