Intuitive Surgical recalls 8MM Mega Needle Driver models with frayed grip cables that could cause injury during use. Affected units include specific batch numbers and model 470194. Consumers should stop using and contact for replacement.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM Mega Needle Driver surgical instruments due to frayed or broken grip cables that could lead to injury. This recall affects specific batch numbers and model 470194 units sold for surgical procedures.
The grip cables on these reusable surgical instruments can fray or break during use, potentially causing the instrument to slip or malfunction. This could lead to injury to the user or the patient during surgical procedures.
Surgical professionals and hospitals using the affected 8MM Mega Needle Driver models. Those handling the instruments during procedures are at risk of injury from frayed cables.
Check for model number 470194 with batch numbers listed in the recall (e.g., K10221113, K10221128, etc.). The product is sold under the brand Intuitive Surgical for surgical use.
Discontinue use of the affected 8MM Mega Needle Driver models with frayed or broken grip cables to prevent injury.
Reach out to Intuitive Surgical for a replacement or repair of the affected instruments.
The model number is 470194 with specific batch numbers listed in the recall notice.
Check the batch numbers on your instrument, which include codes like K10221113, K10221128, and others listed in the recall.
The recall does not specify a return process; contact Intuitive Surgical directly for replacement or repair.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0858-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0858-2025 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.
