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.
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 hazard is limited to potential tool damage due to instruction misinterpretation, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Xi EndoWrist Stapler Release Kit (SRK), model number 470298. The affected product is the IS4000 Stapler Release Kit instruction card, part number 381401-01.
The recall was initiated because 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 source text does not report any injuries, illnesses, or deaths associated with this recall.
A total of 2,059 units were shipped worldwide, including distribution to the United States and various international locations. The source text does not provide specific instructions for consumers or healthcare providers on how to respond to this recall.
The recalled product
- Product
- STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Spanish 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 Vinci¿…
- 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: 381401-01
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.
See all 16 products in this recall →Related recalls
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See all →- ModerateIntuitive Surgical Recalls da Vinci Xi EndoWrist Stapler Release Kits
FDA (Devices) · 2017-04-12
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