Reported Jan 22, 2025 · Ongoing
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304
Is this the product you have?
8MMLARGE NEEDLE DRIVERIS4000 REF 470006
- Lot codes and dates
- Model Number470006
- Part Number470006-12
- UDI-DI code00886874112151
- Batch NumbersK10230120 K10230118 K12230119
- K11230118 K10230217 Part Number470006-13
- UDI-DI code00886874112151
- Batch NumbersK10230623 K10240506 K10240815
- Amount recalled
- 10,603
This recall covers 39 products
The agency filed one notice per product. You are reading one of them; the other 38 are below.
26 more are in the archive.
Where it was sold
Why it was recalled
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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