Silex Medical recalls Debakey Grasper instruments with exposed shaft areas due to incomplete insulation. Affected models include 5862100 with specific serial numbers and lot numbers.
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 Debakey Grasper laparoscopic instruments with a potential exposed electrical area near the rotator wheel. This could cause electrical shock during surgery if the instrument is mishandled.
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 accidentally contacted during surgery.
Surgical teams using the specific model 5862100 instruments with serial numbers 1932-1939 or lot number M28183 are most at risk. These instruments are used in laparoscopic procedures.
Check for model number 5862100 with serial numbers 1932 through 1939 or lot number M28183. The UDI-DI code B33158621000 also identifies affected units.
Review the serial numbers and lot number on the instrument to confirm if it is affected.
The recall addresses a potential electrical hazard due to incomplete insulation, but the risk of serious injury is low as the hazard is specific to surgical use and not typical handling.
Check for model number 5862100 with serial numbers 1932-1939 or lot number M28183. The UDI-DI code B33158621000 also identifies affected units.
The recall does not specify a remedy, so contact Silex Medical directly for guidance on 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-1895-2025 — Silex Medical Silex Medical Hello, I own a Silex Medical that is covered by recall Z-1895-2025 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.
