Intuitive Surgical recalls da Vinci Xi EndoWrist Stapler 45 Reload Green (Model 48445G-03) due to potential missing knife component causing failure to cut tissue. Affected units sold until 2020.
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler 45 Reload Green units (Model 48445G-03) because they may be missing a knife component. This could prevent the stapler from cutting tissue properly when fired. The recall affects units sold until 2020.
The reload knife may not move or cut tissue when the stapler is fired because a component of the knife mechanism is missing. This could lead to improper tissue handling during surgical procedures.
Surgical professionals using the da Vinci Xi EndoWrist Stapler 45 Reload Green (Model 48445G-03) are most at risk. The recall applies to units sold between 2017 and 2020.
Check for the model number 48445G-03 on the product packaging. The product was sold with a device expiration date of 10/14/2017 and 02/21/2020.
Verify the model number on the packaging to confirm if it matches 48445G-03.
The da Vinci Xi EndoWrist Stapler 45 Reload Green (Model 48445G-03) may be missing a component of the knife mechanism, which could prevent the stapler from cutting tissue when fired.
The recall record does not specify a remedy, so no action is required beyond checking the model number.
The product was sold with a device expiration date of 10/14/2017 and 02/21/2020.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2381-2018 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2381-2018 from Intuitive Surgical. 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.
