Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System
Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System 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 medical device with a functional defect that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling 21,684 units of Fenestrated Bipolar Forceps (Model numbers 428093-12 and 428093-13) used with the da Vinci Si Surgical System (IS3000). The recall covers all lots of these specific model numbers.
The recall is being issued 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 use of the instruments.
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
- Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. 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…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 21,684
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: 428093-12
- 428093-13
- 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.
See all 9 products in this recall →Related recalls
Same manufacturer · Intuitive Surgical, Inc.
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Highda Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighIntuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Cautery Plug Defect
FDA (Devices) · 2013-06-05
- ModerateIntuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls 8mm Precise Bipolar Forceps Due to Cautery Plug Defect
FDA (Devices) · 2013-06-05
- ModerateIntuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions
FDA (Devices) · 2013-11-06
- ModerateIntuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Cautery Plug Defect
FDA (Devices) · 2013-06-05