Intuitive Surgical Recalls 8mm Large Needle Driver Instruments
Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of mechanical failure (surface degradation and accelerated wear) that could compromise instrument control, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of the 8mm Large Needle Driver (Part number: 470006-04). These instruments are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall includes all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
The recall is being issued because deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. The affected instruments were distributed in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities and users should stop using the affected instruments and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- 8MM,LARGE NEEDLE DRIVER; 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 (1)
- Part number: 470006-04
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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