Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Errors
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
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 2/5 (Moderate).
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. The stated hazard is damage to the tool resulting from misinterpretation of instructions, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for minor labeling/instruction errors.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Xi EndoWrist Stapler Release Kit (SRK), model number 470298, and related stapler accessories. The recall involves 2,059 units shipped worldwide, including distribution to the United States and numerous international markets.
The recall was initiated after Intuitive Surgical determined that misinterpretation of the instructions provided on the IS4000 Stapler Release Kit instruction card may result in damage to the tool. The devices are intended for use with the da Vinci Xi Surgical System for resection, transection, and creation of anastomoses in various surgical procedures.
Healthcare facilities and users should stop using the affected products and contact Intuitive Surgical for further instructions on how to proceed.
The recalled product
- Product
- STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi French SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,059
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 (1)
- Part number: 381385-01
Distribution
Part of a larger recall action
This product is one of 16 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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