Device recall

Z-1698-2026: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci…

FDA device recall · Class II · Intuitive Surgical, Inc.

Key facts

Recall number (Z-number) Z-1698-2026
Recall event 98383
Product Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors…
Product code NAY
Recalling firm Intuitive Surgical, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K050369
FEI number 3001675293

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)