Intuitive Surgical recalls Ion Vision Probe Bags (model 490127) due to potential compromised sterile pouch seals. These single-use bags, used with their robotic surgery system, may not be sterile after packaging. Affected units include specific batch numbers listed in the recall notice.
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Intuitive Surgical is recalling Ion Vision Probe Bags (model 490127) because some units may have a compromised or incomplete sterile pouch seal. This could lead to the bags not being sterile when used, potentially causing infections during surgery. The bags are part of their robotic surgical system.
The Vision Probe Bag is a single-use sterile pouch that holds the Vision Probe (a surgical tool) during procedures. If the pouch seal is compromised or incomplete, the bag may not maintain sterility after packaging. This could lead to contamination of the surgical tool during procedures, increasing infection risk.
Users of Intuitive Surgical's robotic surgery systems who own or use the Ion Vision Probe Bags (model 490127) are affected. The risk is low because the bags are single-use and the seal issue is unlikely to cause serious injury if the bag is used properly.
Check for the model number 490127 on the bag. Affected units include specific batch numbers listed in the recall notice, such as DM01232816 through DM01253002. The bags are part of Intuitive Surgical's robotic surgery system.
Look for the model number 490127 on the Vision Probe Bag. Affected units have batch numbers from DM01232816 to DM01253002.
If your bag is affected, contact Intuitive Surgical directly for instructions on how to return it.
The Vision Probe Bag may have a compromised or incomplete sterile pouch seal, which could lead to contamination during surgery.
Check for the model number 490127 and batch numbers from DM01232816 to DM01253002 on the bag.
No action is needed if your bag is not affected by the batch numbers listed in the recall.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1134-2026 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1134-2026 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.
