Intuitive Surgical Recalls da Vinci Si Maryland Bipolar Forceps
Intuitive Surgical is recalling 13,644 Maryland Bipolar Forceps used with the da Vinci Si Surgical System because the instrument 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 is classified as FDA Class II, and the hazard involves a mechanical failure of a surgical instrument that poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 13,644 units of Maryland Bipolar Forceps (Model numbers 428080-04 and 428080-05) used with the da Vinci Si Surgical System (IS3000). The recall covers all lots of these specific models.
The recall was initiated 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 use of the instrument during surgical procedures.
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 of these instruments should contact Intuitive Surgical for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. 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
- 13,644
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: 428080-04
- 428080-05
- 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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