Intuitive Surgical Recalls 8mm Tip-Up Fenestrated Graspers for Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Tip-Up Fenestrated Graspers because deviations in reprocessing steps can cause surface degradation and mechanical wear.
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 source text describes a risk of surface degradation and mechanical wear due to reprocessing deviations, but does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm, Tip-Up Fenestrated Graspers. These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The affected units are all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings, identified by part number 470347-04.
The recall is due to deviations in reprocessing steps from those stated in the reprocessing instructions. These deviations can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
The affected devices were distributed in the United States to Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts. Users should contact Intuitive Surgical for further instructions regarding the recall.
The recalled product
- Product
- 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 509
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 (2)
- Part number
- 470347-04
Distribution
Part of a larger recall action
This product is one of 22 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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