Intuitive Surgical recalls da Vinci Xi and X surgical systems (IS40:000 and IS4200) due to incorrect expiration dates on packaging, which could lead to improper use of sterile components.
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Intuitive Surgical is recalling the da Vinci Xi and X surgical systems (model IS4000 and IS4200) because the packaging labels have incorrect expiration dates. This could mean the sterile instrument arm drapes might not be safe for use, potentially leading to infection risks during surgery.
The instrument arm drapes are sterile and intended for single use. If the expiration date is incorrect, the drapes might not be safe for surgery, increasing the risk of infection.
Surgical teams using the da Vinci Xi or X systems (model IS4000 or IS4200) are affected. The risk is highest for hospitals and surgical centers that use these systems.
Check for the da Vinci Xi or X surgical systems (model IS4000 or IS4200) with part number 470015-07 and lot number DM4210309.
Verify the expiration date on the package label for the instrument arm drapes (part number 470015-07).
The recall is due to incorrect expiration dates on the packaging labels of the instrument arm drapes, which could lead to unsafe use.
Yes, the drapes are sterile and intended for single use when the expiration date is correct.
Check the expiration date on the package label for the instrument arm drapes (part number 470015-07). If incorrect, contact Intuitive Surgical for guidance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0275-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0275-2022 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.
