Richard Wolf recalls E-Line Cutting Electrode 11.5Fr Mono 0 degrees due to incorrect electrode in package. This may cause improper use during medical procedures. Affected units have product number 8416.0305.
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Richard Wolf is recalling E-Line Cutting Electrodes because the package contains the wrong electrode model. Using the incorrect electrode could lead to improper medical procedures during surgeries or treatments.
The package contains E-Line Hook Electrode 8416.09 instead of the intended E-Line Cutting Electrode 8416.03. This mismatch could cause improper tissue ablation during medical procedures, potentially leading to ineffective treatments or complications.
Medical professionals using the E-Line Cutting Electrode 11.5Fr Mono 0 degrees in urology or gynecology procedures are likely affected. Patients undergoing these procedures may be at risk if the wrong electrode is used.
Check for product number 8416.0305 on the package. The electrodes come in a white box with five units each placed in a plastic tray and inserted into a Tyvek pouch.
Verify that the package contains E-Line Cutting Electrode 8416.03 instead of E-Line Hook Electrode 8416.09.
The product number is 8416.0305.
The batch number is 1390827.
Look for product number 8416.0305 on the package. The electrodes come in a white box with five units each placed in a plastic tray and inserted into a Tyvek pouch.
We’ve drafted a message you can send Richard Wolf to request your refund or repair — edit it as you like.
Subject: Recall Z-1957-2019 — Richard Wolf Richard Wolf Hello, I own a Richard Wolf that is covered by recall Z-1957-2019 from Richard Wolf. 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.