Aesculap recalls SEALING UNIT F/10/12MM TROCARS with model EK083P due to potential silicone fragments detaching from the sealing component. Affected units may cause injury if fragments enter the body during surgery.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Aesculap is recalling its SEALING UNIT F/10/12MM TROCARS with model EK083P because silicone fragments could detach from the sealing component during use. This poses a risk of injury if fragments enter the body during surgical procedures.
Silicone fragments may detach from the yellow sealing component during use. If fragments enter the body during surgery, they could cause injury or infection. The hazard is specific to the sealing component design.
Surgical professionals using the SEALING UNIT F/10/12MM TROCARS with model EK083P for procedures. Those at highest risk are medical staff handling the product during surgeries.
Check for the model number EK083P on the product. Affected units were sold with specific lot numbers: 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167.
Look for the model number EK083P on the product to confirm if it is affected.
Reach out to Aesculap Inc for further instructions on handling the recalled product.
The recall is due to potential silicone fragments detaching from the yellow sealing component, which could cause injury if fragments enter the body during surgery.
Check the model number and lot numbers to confirm if your product is affected. Contact Aesculap Inc for further instructions.
The recall states there is a potential for silicone fragments to detach, which could cause injury during surgery, but the exact risk level is not specified in the notice.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-0309-2026 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-0309-2026 from Aesculap. 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.
