Silex Medical recalls laparoscopic instruments with exposed shaft areas due to incomplete insulation. Affected models include 5862030 with specific serial numbers. Contact for remedy.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical is recalling laparoscopic instruments where the electrical insulation on the shaft may not cover the entire length. This could expose users to electrical shock during surgery if the instrument is mishandled.
The insulation on the instrument's tube does not extend fully to the proximal end of the shaft, creating an exposed electrical area near the rotator wheel. If the instrument is mishandled during surgery, this could cause electrical shock.
Surgical teams using the specific model of laparoscopic instruments with serial numbers 0709-0720 are most at risk. These instruments were sold in the U.S. between 2020 and 2021.
Check for model number 5862030 and serial numbers 0709 through 0720 on the instrument. These instruments were sold in the U.S. from 2020 to 2021.
Look for model number 5862030 and serial numbers 0709-0720 on the instrument.
The insulation on the tube does not extend fully to the proximal end of the shaft, leaving an exposed electrical area near the rotator wheel.
The recall record does not specify a remedy, so contact Silex Medical for further instructions.
These instruments were sold in the U.S. between 2020 and 2021.
We’ve drafted a message you can send Silex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1894-2025 — Silex Medical Silex Medical Hello, I own a Silex Medical that is covered by recall Z-1894-2025 from Silex Medical. 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.
