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Medline Renewal Ligasure Blunt Tip Sealer/Divider… recallZ-0474-2026 · Medline Industries, LP · initiated Oct 1, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail. The notice explained the issue, potential risk to health, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-206 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."

Recall details

Recall number
Z-0474-2026
Status
Open, Classified
Initiated by the company
Oct 1, 2025
Posted by the FDA
Nov 7, 2025
Recalling firm
Medline Industries, LP
Quantity
1,446 units
Product code
NUJ
FDA submissions
K160333
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 10888277680418 (each), 20888277680415 (case), All Lots

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97822).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page