Reported Apr 8, 2026 · Ongoing
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument…
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?
- Brand Nameda Vinci S, Si Mega
- Needle Driver Instrument Product Nameda Vinci S, Si Mega Needle
- Driver Instrument Model/Catalog Number420194
- Software VersionNA
- Product DescriptionEndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient)
- ComponentNA
- Lot codes and dates
- Lot Code420194
- Mega Needle Driver GTIN00886874111611
- FDA Medical Device Listing NumberD088920
- Material Number420194-08
- Batch / System Numbers
339 of 339 codes
M10120201SH1182M20120412SH1182M10130121SH1570M10130306SH1570M10110602SH0547M10110627SH0547M10121129SH0059M10121214SH0059M10130429SH0059M10130521SH0059M10121105SH1557M10130517SH1837M10121109SH1390M10130508SH1390M10131004SH1390M10130306USG689M10130412USG689M10110302SH1368M10110614SH1368M10110620SH1368M10110817SH1368M10120705SH1368M10121022SH1368M10130429SH1368M10130509SH1368M10130722SH1368M10110131USG294M10110511USG294M10110616USG294M10110811USG294
- USG518 M10131014 USG518 Material Number420194-10
- Batch / System Numbers
609 of 609 codes
N10170714SH1182N10170817SH1182N10171019SH1182M10140303SH1570N10140805SH1570N10150702SH1570N10160311SH1570N10160421SH1570N10161206SH1570N10161223SH1570N10180227SG704M10131121SH0547N10140609SH0547M10140221SH0059M10140307SH0059N10140508SH0059N10140827SH0059N10150320SH0059N10160519SH0059N10160728SH0059N11160907SH0059N11161013SH0059N10161129SH0059N10170419SH0059N11170407SH0059N10170612SH0059N10170705SH0059N10180202SH0059N10180323SH0059N10180321SH0059
- USG518 N10170103 USG518 Material Number420194-12
- Batch / System Numbers
137 of 137 codes
N10190729SH1182N10180921SH1557N10190104SH1557N10190211SH1557N10190326SH1557N12190423SH1557N10190719SH1557N11191021SH1557N10191216SH1557N10210329SH1557N10210524SH1557N10210517SH1557N10190108SH1837N10200727SH1837N10201012SH1837N10201103SH1837N10210412SH1837N10191111USG689N10191125USG689N10190805SH1368N10190930SH1368N10180808USG294N10180906SH2186N10190522SH2186N10201012SH2186N10190226SH0825N10190326SH0825N10210412SH0825N10181126SH0729N10190107SH0729
- SH1279 N10210607 SH1279 Material Number420194-13
- Batch / System NumbersK11220626 SH1964 K10220228 SH1837
- Amount recalled
- 7819
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to increased complaints for broken/frayed grip cables for reusable instruments.
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.