Reported Jan 22, 2025 · Ongoing
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
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 SUTURECUT NEEDLE DRIVERIS4000¿ REF 470296
- Lot codes and dates
- Model Number470296
- Part Number470296-05
- UDI-DI code00886874112410
- Batch NumbersK10230217
- Model Number470296
- Part Number470296-08
- UDI-DI code00886874112410
- Batch Numbers
K10230302K10230413K10230420K10230427K10230824K10231123K10240229K10240425K10240627K10240718K16240613
- Amount recalled
- 784
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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