FDA (Devices) recall action 97822

Medline Industries, LP recalled 11 products on 2025-11-19

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2025-11-19
Critical: 0
Units: 214,071

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

HighFDA (Devices)··2025-11-19
Small jaw sealers recalled over residual material that may dislodge
Medline is recalling 18,117 reprocessed LigaSure Small Jaw instruments because certain areas of the device can trap residual material that may become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Reprocessed vessel sealers recalled over residual material that may dislodge
Medline is recalling 57,244 reprocessed LigaSure Maryland Jaw sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Blunt tip sealers recalled over residual material trapped inside the device
Medline is recalling 60,917 reprocessed LigaSure Blunt Tip sealer/dividers, 37 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Short blunt tip sealers recalled over residual material that may dislodge
Medline is recalling 65 reprocessed LigaSure Blunt Tip sealer/dividers, 23 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Blunt tip sealers 44 cm recalled over trapped residual material
Medline is recalling 1,446 reprocessed LigaSure Blunt Tip sealer/dividers, 44 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
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
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
LigaSure Exact dissectors recalled over residual material that may dislodge
Medline is recalling 4,226 reprocessed LigaSure Exact dissectors, 21 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Curved large jaw sealers recalled over residual material that may dislodge
Medline is recalling one reprocessed LigaSure Impact Curved Large Jaw sealer/divider because certain areas of the device can trap residual material that may become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Maryland jaw sealers 23 cm recalled over residual material inside the device
Medline is recalling 4,007 reprocessed LigaSure Maryland Jaw sealer/dividers, 23 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Five millimetre blunt tip sealers recalled over trapped residual material
Medline is recalling two reprocessed LigaSure Blunt Tip sealer/dividers, 5 mm x 37 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Impact vessel sealers recalled over residual material that may dislodge
Medline is recalling 58,499 reprocessed LigaSure Impact sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.
Product
Medline 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, Reprocessed
Category
Distribution
0 states
HighFDA (Devices)··2025-11-19
Maryland jaw sealers 44 cm recalled over trapped residual material
Medline is recalling 9,547 reprocessed LigaSure Maryland Jaw sealer/dividers, 44 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
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
Category
Distribution
0 states