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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Renewal LigaSure Exact, Dissector

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 Class 2 Device Recall Medline Renewal LigaSure Exact, Dissectorsee related information
Date Initiated by FirmOctober 01, 2025
Date PostedNovember 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0467-2026
Recall Event ID 97822
510(K)NumberK232511 
Product Classification Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed - Product Code NUJ
ProductMedline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
Code Information UDI/DI 20193489189688 (each), 10193489189681 (case), All Lots
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline 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 recalls@medline.com."
Quantity in Commerce4226 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NUJ
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