Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference
Intuitive Surgical is recalling 3,282 EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical defect (grip interference) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 3,282 units of the EndoWrist One Vessel Sealer, IS3000, 6 pack. This bipolar electrosurgical instrument is used with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator for coagulation and transection of vessels up to 7mm in diameter.
The recall was initiated because a small portion of the instruments may exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws. The affected units were distributed nationwide in the United States and internationally to 20 countries, including Australia, Belgium, China, and the United Kingdom.
Healthcare providers and facilities should stop using the affected EndoWrist One Vessel Sealers and contact Intuitive Surgical for further instructions. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is i
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 3,282
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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