Silex Medical recalls laparoscopic instruments with exposed shaft areas due to incomplete insulation. Affected models include specific serial numbers and lot numbers. Consumers should contact the manufacturer for 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 surgical instruments that have an exposed area of the shaft due to incomplete insulation. This could cause electrical shock during surgery if the instrument is mishandled. The recall affects specific model numbers and serial ranges.
The insulation on the instrument's tube did not extend fully to the proximal end of the shaft, leaving an exposed area closer to the rotator wheel. This exposed section could cause electrical shock if the instrument comes into contact with a conductive surface during surgical procedures.
Surgical professionals using the specific model of laparoscopic instruments with serial numbers 9565-9670 are affected. Patients undergoing surgery with these instruments may be at risk of electrical shock.
Check if your instrument has the model number 5864000 and serial numbers from 9565 to 9670. The lot number M28187 and UDI-DI B33158640000 are also associated with this recall.
Verify your instrument's model number (5864000) and serial numbers (9565-9670) to confirm if it is affected.
The insulation on the tube did not extend fully to the proximal end of the shaft, leaving an exposed area closer to the rotator wheel that could cause electrical shock.
Check for model number 5864000 and serial numbers from 9565 to 9670. The lot number M28187 and UDI-DI B33158640000 are also associated with this recall.
Contact Silex Medical directly to confirm if your instrument is affected and follow their instructions for next steps.
We’ve drafted a message you can send Silex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1899-2025 — Silex Medical Silex Medical Hello, I own a Silex Medical that is covered by recall Z-1899-2025 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.
