MEDLINE recalls ReNewal Ligasure Sealer/Divider Nano-Coated devices with incomplete packaging seals. Affected units may have packaging that doesn't seal properly, potentially leading to contamination risks during use.
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
MEDLINE is recalling ReNewal Ligasure Sealer/Divider Nano-Coated devices that may have incomplete packaging seals. This could lead to contamination risks during surgical procedures if the packaging isn't properly sealed.
The packaging may not seal completely, which could allow contaminants to enter the device during use. This poses a contamination risk in sterile surgical environments but does not affect the device's operational function.
Surgical professionals using MEDLINE ReNewal Ligasure Sealer/Divider devices with specific lot numbers are affected. The risk is low as the issue relates to packaging integrity rather than device function.
Check for lot numbers 498352, 498405, 498459, 498890, 498937, 499048, 499050, 499052, 499062, 499063, 499145, 499155, 499218, 499267, 499269, 499271, 499299, 499343 on the device packaging.
Inspect the packaging for signs of incomplete sealing, such as gaps or leaks.
The recalled device is MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated compatible with FT10 Generator, model REF LF4418CR.
Check for lot numbers 498352, 498405, 498459, 498890, 498937, 499048, 499050, 499052, 499062, 499063, 499145, 499155, 499218, 499267, 499269, 499271, 499299, 499343 on the device packaging.
No, the recall does not require immediate discontinuation. Affected devices can be used if the packaging seal is intact.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-0119-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-0119-2024 from MEDLINE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
