Silex Medical recalls specific laparoscopic instruments with exposed electrical areas that could cause electrical shock during surgery. Affected models include 5863030 with serial numbers 0446-0451. Contact for remedy details.
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 with a potential electrical hazard. The insulation on the tube may not extend fully, exposing part of the shaft near the rotator wheel. This could cause electrical shock during surgery if the instrument is used improperly.
The insulation on the tube does not fully cover the shaft near the rotator wheel, creating an exposed electrical area. This could lead to electrical shock if the instrument is used improperly during surgery, though the risk is low in normal use.
Surgical teams using the specific laparoscopic instruments with model number 5863030 and serial numbers 0446-0451 are most at risk. These instruments are used in medical procedures.
Check for model number 5863030 and serial numbers 0446 through 0451 on the instrument. The product was sold with UDI-DI B33158630300 and lot number M28185.
Verify the model number and serial numbers to confirm if your instrument is affected.
The model number is 5863030 with serial numbers 0446 through 0451.
The recall record does not specify a remedy.
Check for model number 5863030 and serial numbers 0446-0451 on the instrument.
We’ve drafted a message you can send Silex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1897-2025 — Silex Medical Silex Medical Hello, I own a Silex Medical that is covered by recall Z-1897-2025 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.
