Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk
Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a functional defect (detachment) in a surgical instrument. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Intuitive Surgical, Inc. is recalling Large Needle Driver, 8MM assemblies used with the da Vinci S IS1200 and da Vinci Si IS2000 systems. The recall was initiated because the firm became aware of the potential for the jaw insert to detach from the instrument. These EndoWrist instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, and suturing.
The affected units were distributed worldwide, including nationwide in the United States and Puerto Rico, as well as internationally to Finland, Belgium, the Netherlands, the UK, the Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia. The recall covers specific part numbers 400006 and 420006 across numerous lot numbers listed in the official recall documentation.
Healthcare facilities and users should stop using the affected Large Needle Drivers and contact Intuitive Surgical for further instructions on the recall process. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
- Manufacturer
- Intuitive Surgical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part number 400006 on da Vinci IS1200
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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