Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments 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 is classified as FDA Class II and involves a risk-of-harm product (mechanical wear/surface degradation) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of the 8mm Atrial Retractor Short Right instrument. These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall affects all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings, identified by part number 470246-04.
The recall was initiated 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 agency has classified this recall as Class II.
The affected devices were distributed in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts. Healthcare facilities should contact Intuitive Surgical, Inc. for instructions on how to manage the recalled devices.
The recalled product
- Product
- 8MM, ATRIAL RETRACTOR SHORT RIGHT ; 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
- 470246-04
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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