Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers
Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.
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: The recall involves a high-risk medical device where a mechanical failure could impede surgical procedures, but the source text does not report any injuries or illnesses, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 89 units of the Needle Driver used with the da Vinci Si Surgical System (IS3000). The affected model numbers are 428056-12 and 428056-13. These instruments are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue during single incision laparoscopic cholecystectomy.
The recall is being issued because, in certain circumstances, the jaws of the grip actuated instruments may become fixed in a closed position. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected units were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom. Healthcare facilities should contact Intuitive Surgical for instructions on how to return or replace the affected instruments.
The recalled product
- Product
- Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 89
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 (3)
- Model numbers: 428056-12
- 428056-13
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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Similar recalls
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