FDA Device recall Z-3094-2024
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower by Medline Industries Northfield, citing potential for an incomplete seal on the packaging tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3094-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-07 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Reason
Potential for an incomplete seal on the packaging tray.
Identifiers
| code_info | Item Number: LF4418CR. UDI/DI: 20888277680446 (case), 10888277680449 (each). Lot Numbers: 500376, 500379, 500380, 50038…Item Number: LF4418CR. UDI/DI: 20888277680446 (case), 10888277680449 (each). Lot Numbers: 500376, 500379, 500380, 500381, 500382, 500504, 500506, 500548, 500559, 500652, 500695, 500874, 503004, 503289. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3094-2024%22
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