Intuitive Surgical Recalls 8mm Potts Scissors Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
What this means for you
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 high-risk medical device where mechanical wear and surface degradation pose a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm Potts Scissors (Part number: 470001-04). 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 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 instruments were distributed in the United States to Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
The recalled product
- Product
- 8MM,POTTS SCISSORS; 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: 470001-04
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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