Drug recall
Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW…
FDA recall event 97822 · Class II · Medline Industries, LP
Key facts
| Event ID | 97822 |
|---|---|
| Recall numbers | Z-0467-2026, Z-0468-2026, Z-0469-2026, Z-0470-2026, Z-0471-2026, Z-0472-2026, Z-0473-2026, Z-0474-2026, Z-0475-2026, Z-0476-2026, Z-0477-2026 |
| Recalling firm | Medline Industries, LP |
| Product type | Devices |
| Products | 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 &…, 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 &…, 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 &…, 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 &…, Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device and 6 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 1, 2025 |
| Report date | Nov 19, 2025 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: