Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
General, Plastic Surgery · 21 CFR 878.4400
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Recent MDR events
772 adverse event reports on file
- NAJul 20, 2026MalfunctionStryker Endoscopy-san Jose0001056128-2026-00043
- MEDLINEJun 30, 2026MalfunctionMedline Renewal3032391-2026-00053
- ENDOPATH ENDOSCOPIC INSTRUMENT, CURVED SCISSORS W/MONOPOLAR CAUTERYJun 26, 2026MalfunctionMedline Renewal3032391-2026-00052
- SERFAS ENERGY 90-S CRUISEJun 11, 2026MalfunctionMedline Renewal3032391-2026-00030
- STRYKER SERFAS ENERGY PROBESMay 22, 2026MalfunctionMedline Renewal3032391-2026-00020
- ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPICApr 30, 2026MalfunctionMedline Renewal3032391-2026-00005
- NAApr 8, 2026MalfunctionStryker-endoscopy Lakeland 53000001056128-2026-00024
- NAApr 6, 2026MalfunctionStryker-endoscopy Lakeland 53000001056128-2026-00022
- N/AApr 3, 2026MalfunctionStryker Sustainability Solutions, Inc.24775793
- NAFeb 12, 2026MalfunctionStryker-endoscopy Lakeland 53000001056128-2026-00011
Event type breakdown
Recalls
20 recall events for this product code
- Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version
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.
Z-0467-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & C
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.
Z-0468-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 Generator 18cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coa
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.
Z-0469-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10
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.
Z-0470-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
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 & Co
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.
Z-0471-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting &
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.
Z-0472-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
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 &
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.
Z-0473-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting &
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.
Z-0474-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
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, Cutti
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.
Z-0475-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedNov 7, 2025
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulati
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.
Z-0476-2026 · View FDA record ↗
Registered firms
83 firms currently registered for this product code
Stryker Sustainability Solutions
Tempe, AZ, US
Stryker Sustainability Solutions Lakeland
LAKELAND, FL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Northeast Scientific, Inc.
Waterbury, CT, US
Sterigenics U.s., Llc
Atlanta, GA, US
Isomedix Operations Inc.
GRAND PRAIRIE, TX, US
Suretek Medical
GREENVILLE, SC, US
Green Or Llc
Lakeville, MN, US
Stryker Tijuana Operations
Tijuana Baja California, MX
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Stryker Sustainability Solutions - Chandler
Chandler, AZ, US
Isomedix Operations Inc.
SAN DIEGO, CA, US
Nypro Inc (maple Grove)
Maple Grove, MN, US
510(k) clearances
37 clearances for this product code
- Surgical Instrument Service and Savings, Inc.Apr 29, 2024
K232511 · Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
- Stryker Sustainability SolutionsMar 28, 2023
K230251 · Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- Stryker Sustainability SolutionsMay 13, 2022
K220411 · Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- Green Or, LLCApr 7, 2022
K211203 · Green OR Reprocessed Aquamantys Bipolar Sealer
- Vein 360, LLCOct 22, 2019
K191073 · Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
- Surgical Instrument Service and Savings Inc.(Dba Medline RenOct 31, 2018
K182588 · Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
- Stryker Sustainability SolutionsApr 23, 2018
K180499 · Reprocessed LigaSure Maryland Jaw Sealer/Divider
- Stryker Sustainability SolutionsApr 20, 2018
K180451 · Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider