Medline Renewal LigaSure Devices Recalled for Potential Material Trapping

Agency Publication Date: November 7, 2025

Summary

Medline Renewal is recalling 214,071 units of various reprocessed LigaSure electrosurgical devices, including the Exact, Impact, Small Jaw, Blunt Tip, and Maryland Jaw models. These devices, used for cutting and sealing tissue during surgery, are compatible with the FT10 Generator running software version 4.0.1.15 or lower. Medline determined that certain areas on these devices can trap residual material from previous uses, which may remain inside and potentially dislodge during a surgical procedure.

Risk

The trapped material could become dislodged and enter a patient's body during surgery, which poses a risk of infection, inflammatory response, or other complications from foreign material.

What You Should Do

This recall affects Medline Renewal LigaSure devices (Exact, Impact, Small Jaw, Blunt Tip, and Maryland Jaw models) compatible with the FT10 Generator running software version 4.0.1.15 or lower. Affected products include various lengths from 18 cm to 44 cm.
Check your medical facility's inventory for the specific UDI/DI codes and model names listed on the product packaging. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately and quarantine any remaining stock to prevent further clinical use.
Contact Medline Renewal or your Medline Industries distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Renewal LigaSure Exact, Dissector without Nano-Coating (21cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

20193489189688 (each)

10193489189681 (case)

Electrosurgical Cutting And Coagulation Device; Recall #: Z-0467-2026

Product: Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider (Reprocessed)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680432 (each)

20888277680439 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0468-2026

Product: Medline Renewal Ligasure Impact Sealer/Divider NanoCoated (18cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680449 (each)

20888277680446 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0469-2026

Product: Medline Renewal LigaSure Small Jaw Instrument (Purple/White) (18.8 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680326 (each)

20888277680323 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0470-2026

Product: Medline Renewal LigaSure Blunt Tip Sealer/Divider (5 mm x 37 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680340 (each)

20888277680347 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0471-2026

Product: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated (23 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680371 (each)

20888277680378 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0472-2026

Product: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated (37 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680395 (each)

20888277680392 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0473-2026

Product: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated (44 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680418 (each)

20888277680415 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0474-2026

Product: Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated (23 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277719392 (each)

20888277719399 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0475-2026

Product: Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated (37 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277719415 (each)

20888277719412 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0476-2026

Product: Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated (44 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277719439 (each)

20888277719436 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0477-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97822

Status: Active

Manufacturer: Medline Industries, LP

Sold By: Authorized Medline Distributors; Medline Industries, LP

Manufactured In: United States

Units Affected: 11 products (4226 units; 1 unit; 58,499 units; 18,117 units; 2 units; 65 units; 60,917 units; 1,446 units; 4,007 units; 57,244 units; 9,547 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Medline Renewal LigaSure devices (Exact, Impact, Small Jaw, Blunt Tip, and Maryland Jaw models) compatible with the FT10 Generator running software version 4.0.1.15 or lower. Affected products include various lengths from 18 cm to 44 cm.

Check your medical facility's inventory for the specific UDI/DI codes and model names listed on the product packaging. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately and quarantine any remaining stock to prevent further clinical use.

Contact Medline Renewal or your Medline Industries distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Affected Products

Product: Medline Renewal LigaSure Exact, Dissector without Nano-Coating (21cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

20193489189688 (each)

10193489189681 (case)

Electrosurgical Cutting And Coagulation Device; Recall #: Z-0467-2026

Product: Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider (Reprocessed)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680432 (each)

20888277680439 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0468-2026

Product: Medline Renewal Ligasure Impact Sealer/Divider NanoCoated (18cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680449 (each)

20888277680446 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0469-2026

Product: Medline Renewal LigaSure Small Jaw Instrument (Purple/White) (18.8 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680326 (each)

20888277680323 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0470-2026

Product: Medline Renewal LigaSure Blunt Tip Sealer/Divider (5 mm x 37 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680340 (each)

20888277680347 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0471-2026

Product: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated (23 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680371 (each)

20888277680378 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0472-2026

Product: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated (37 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680395 (each)

20888277680392 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0473-2026

Product: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated (44 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277680418 (each)

20888277680415 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0474-2026

Product: Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated (23 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277719392 (each)

20888277719399 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0475-2026

Product: Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated (37 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277719415 (each)

20888277719412 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0476-2026

Product: Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated (44 cm)

Variants: FT10 SW Version 4.0.1.15 or lower

Lot Numbers:

All Lots

UDI:

10888277719439 (each)

20888277719436 (case)

Laparoscopic & Endoscopic accessories; Recall #: Z-0477-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97822

Status: Active

Manufacturer: Medline Industries, LP

Sold By: Authorized Medline Distributors; Medline Industries, LP

Manufactured In: United States

Units Affected: 11 products (4226 units; 1 unit; 58,499 units; 18,117 units; 2 units; 65 units; 60,917 units; 1,446 units; 4,007 units; 57,244 units; 9,547 units)

Distributed To: Nationwide