United StatesMedline Renewal LigaSure electrosurgical devices and accessories (multiple models and lengths listed as “Medline Renewal LigaSure” and described as compatible with the FT10 generator, FT10 SW Version 4.0.1.15 or lower, all lots and specified UDI/DIs) sold nationwide in the U.S. are affected. The firm recalled them after determining certain areas can trap residual material that may remain in the device and, in rare cases, become dislodged.
What's being recalled
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
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
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
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
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
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
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
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
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
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
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
Recalling firm: Medline Industries, LP, Northfield, IL, United States.
How to identify it
UDI/DI 20193489189688 (each), 10193489189681 (case), All Lots UDI/DI 10888277680432 (each), 20888277680439 (case), All Lots UDI/DI 10888277680449 (each), 20888277680446 (case), All Lots UDI/DI 10888277680326 (each), 20888277680323 (case), All Lots UDI/DI 10888277680340 (each), 20888277680347 (case), All Lots UDI/DI 10888277680371 (each), 20888277680378 (case), All Lots UDI/DI 10888277680395 (each), 20888277680392 (case), All Lots UDI/DI 10888277680418 (each), 20888277680415 (case), All Lots UDI/DI 10888277719392 (each), 20888277719399 (case), All Lots UDI/DI 10888277719415 (each), 20888277719412 (case), All Lots UDI/DI 10888277719439 (each), 20888277719436 (case), All Lots
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)