Aesculap recalls Prestige Retraction Graspers with potential handle separation. Affected models include 8361-10 (UDI-DI: 04046955083381) sold in specific lots. Stop using immediately to avoid injury.
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Aesculap is recalling a specific type of surgical grasper that may separate at the weld between the handle and shaft. This separation could cause injury during surgery if the device becomes detached.
The grasper's handle and shaft can become disconnected at the weld point during use. This separation could lead to the device becoming loose or detached, potentially causing injury to the surgical site or patient.
Surgical professionals using the recalled grasper models are affected. Patients undergoing surgery with this device are at risk of injury if the handle separates during procedure.
Check for the product code 8361-10 on the device. Look for UDI-DI: 04046955083381 and lots M45171, M46651, M47463, M48124, or M49436.
Discontinue use of the affected grasper to prevent potential handle separation during surgery.
The product code is 8361-10.
Affected lots are M45171, M46651, M47463, M48124, and M49436.
Check for the product code 8361-10 and UDI-DI: 04046955083381 with the listed lots.
We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.
Subject: Recall Z-1482-2022 — Aesculap Aesculap Hello, I own a Aesculap that is covered by recall Z-1482-2022 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.
