Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
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, but the source text identifies the hazard as potential tool damage due to instruction misinterpretation rather than a direct risk of serious injury or death to patients, aligning with the Moderate severity criteria for lower-risk issues.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Xi EndoWrist Stapler Release Kit (SRK), model number 470298. The recall involves 2,059 units shipped in all languages. The product is intended for use with the da Vinci Xi Surgical System (Model IS4000) for resection, transection, and creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery.
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 agency classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Australia, Canada, Germany, Japan, and the United Kingdom. The specific part number for the affected items is 381215-02.
The recalled product
- Product
- STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi English 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 Vin
- 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: 381215-02
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.
See all 16 products in this recall →Related recalls
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Same hazard · tool damage
See all →- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits
FDA (Devices) · 2017-04-12