Silex Medical recalls Signature Laparoscopic Instruments with exposed electrical shaft due to incomplete insulation. Affected models include 5863050 with specific serial numbers and lot 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 with a risk of electrical exposure because the insulation on the shaft didn't extend fully. This could cause injury if the instrument is used improperly during surgery.
The insulation on the instrument's shaft did not reach the end near the rotator wheel, creating an exposed electrical area. This could cause electrical shock or burns if the instrument comes into contact with bodily fluids or tissues during surgery.
Surgeons and medical staff who use the recalled instruments during procedures are most at risk. Patients may be affected if the instruments are used incorrectly.
Check for model number 5863050 with serial numbers 1051-1059 or lot number M28186. The product was sold with UDI-DI B33158630500.
Verify the model number, serial numbers, and lot number to confirm if your instrument is affected.
The recall is for instruments with incomplete insulation that could cause electrical exposure during surgery, but the remedy is not specified in the record.
The recall record does not specify a remedy, so contact Silex Medical for further instructions.
Check for model number 5863050 with serial numbers 1051-1059 or lot number M28186.
We’ve drafted a message you can send Silex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1898-2025 — Silex Medical Silex Medical Hello, I own a Silex Medical that is covered by recall Z-1898-2025 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.
