Reported Jan 22, 2025 · Ongoing
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
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?
8MMMEGA NEEDLE DRIVERIS4000¿ REF 470194
- Lot codes and dates
- Model Number470194
- Part Number470194-06
- UDI-DI code00886874112342
- Batch Numbers
K10221113K10221128K10221204K10221212K10221218K10230112K10230205K10230212K10230217K10230824K10240418K10240502K10240523K10240718K10240801K11221212K11230112K11230217K11240418K12230112K12230217
- K16240702 U10230217 Model Number470194
- Part Number470194-08
- UDI-DI code00886874112342
- Batch Numbers
73 of 73 codes
K10230302K10230310K10230316K10230323K10230405K10230420K10230511K10230525K10230601K10230608K10230615K10230622K10230706K10230713K10230720K10230727K10230810K10230817K10230907K10230914K10230921K10230928K10231012K10231019K10231027K10231102K10231109K10231123K10231130K10231207K10231214K10240104K10240111K10240118K10240125K10240202K10240208K10240215K10240314K10240327K10240404K10240425K10240509K10240515K10240523K10240606K10240613K10240620K10240627K10240702K10240822K11230302K11230310K11230323K11230720K11230727K11230914K11231012K11231027K11231109
- Amount recalled
- 38,438
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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