Reported Jan 22, 2025 · Ongoing
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
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 SUTURECUT NDIS4000 REF 471309
- Lot codes and dates
- Model Number471309
- Part Number471309-15
- UDI-DI code00886874119815
- Batch Numbers
K10221113K10221115K10221212K10221218K10230103K10230112K10230122K10230124K10230129K10230205K10230212K10230219K10230720K10230824K10240621K10240718K11221113K11221115K11221212K11230103K11230112K11230122K11230202K11230212K11230217K12221113K12221212K12230112K12230122K12230205K12230217K13221113K13230217K14230217K15230217K16240508K16240531
- U10230217 U10230223 Model Number471309
- Part Number471309-16
- UDI-DI code00886874119815
- Batch Numbers
184 of 184 codes
K10230302K10230310K10230316K10230323K10230330K10230413K10230420K10230427K10230504K10230509K10230511K10230518K10230525K10230601K10230608K10230615K10230622K10230630K10230706K10230713K10230727K10230803K10230810K10230817K10230831K10230913K10230914K10230921K10231005K10231012K10231019K10231027K10231102K10231109K10231123K10231130K10231207K10231218K10240104K10240111K10240118K10240125K10240215K10240222K10240229K10240308K10240314K10240321K10240322K10240411K10240418K10240425K10240502K10240516K10240523K10240530K10240606K10240613K10240614K10240619
- Amount recalled
- 88,840
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Intuitive Surgical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.