Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues
Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors 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. The hazard involves mechanical wear and surface degradation which could lead to device failure, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of the 8mm Dual Blade Retractor. These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall involves all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings, identified by part number 470249-04.
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 units were distributed in the United States to facilities in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities should stop using the affected devices and contact Intuitive Surgical for further instructions. This is a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 8MM, DUAL BLADE RETRACTOR; 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
- 470249-04
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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