Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers
Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position 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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (jaws fixed in closed position) in a surgical instrument where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Intuitive Surgical, Inc. is recalling 17,617 units of the Medium-Large Clip Applier used with the da Vinci Si Surgical System (IS3000). The affected model numbers are 428053-12 and 428053-15, and the recall includes all lots. These instruments are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, and other surgical procedures during single incision laparoscopic cholecystectomy.
The recall is being conducted because, in certain circumstances, the jaws of the grip actuated instruments may become fixed in a closed position. This defect could potentially interfere with the intended surgical function of the device.
The affected products 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 and users should stop using the affected instruments and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. 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…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 17,617
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: 428053-12
- 428053-15.
- 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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