Recall Register

Device recall: Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical…

Class II FDA enforcement event 97822. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Medline Industries, LP started this device recall on 1 Oct 2025. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 97822 has 11 product records. The first FDA enforcement report date is 19 Nov 2025. The record gives the status Ongoing.

FDA enforcement reportThe 11 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

US Nationwide distribution.

Recalling firm

Medline Industries, LP, Northfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

11 product records in the event.

FDA event 97822: product records
Recall numberProductQuantityClassStatusReport date
Z-0467-2026Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device4226 unitsClass IIOngoing19 Nov 2025
Z-0468-2026Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed1 unitClass IIOngoing19 Nov 2025
Z-0469-2026Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed58,499 unitsClass IIOngoing19 Nov 2025
Z-0470-2026Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10 Generator 18.8 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed18,117 unitsClass IIOngoing19 Nov 2025
Z-0471-2026Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2 unitsClass IIOngoing19 Nov 2025
Z-0472-2026Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed65 unitsClass IIOngoing19 Nov 2025
Z-0473-2026Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed60,917 unitsClass IIOngoing19 Nov 2025
Z-0474-2026Medline 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, Reprocessed1,446 unitsClass IIOngoing19 Nov 2025
Z-0475-2026Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed4,007 unitsClass IIOngoing19 Nov 2025
Z-0476-2026Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed57,244 unitsClass IIOngoing19 Nov 2025
Z-0477-2026Medline 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, Reprocessed9,547 unitsClass IIOngoing19 Nov 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2025
945
Share of these events in Class II
85%
Product records in this event
11Median of the firm: 5
Events of the firm on the register
66

Other events of the firm

Other FDA enforcement events of Medline Industries, LP
InitiatedProduct (first record)TypeClassRecords
11 Aug 2026Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199ADeviceClass I7
31 Jul 2026Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925ADeviceClass II4
23 Jul 2026Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NDeviceClass II1
20 Jul 2026Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476ADeviceClass II13
13 Jul 2026Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product NumbeDeviceClass II3
10 Jul 2026Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330DeviceClass II1
10 Jul 2026Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295DDeviceClass II11
8 Jul 2026Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SDeviceClass II4
30 Jun 2026Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400ANDeviceClass II4
12 Jun 2026Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, MoDeviceClass II16

Medline Industries, LP: all 66 events

Official channels

Cite this page

Recall Register. FDA enforcement event 97822. https://recallregister.com/fda/ii/97822/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: US Nationwide distribution.
What quantity of product is in FDA event 97822?
The event has 11 product records. The first record gives this quantity: 4226 units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?
85% of the 945 device events that started in 2025 are in Class II.