Intuitive Surgical Recalls 8mm Black Diamond Micro Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps 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 medical device where reprocessing deviations can cause mechanical wear and surface degradation, representing a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm Black Diamond Micro Forceps. These instruments 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 470033-04.
The recall is being conducted 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 units were distributed in the United States to facilities in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities should contact Intuitive Surgical, Inc. for instructions on how to return the affected instruments. Users should stop using the affected forceps until further notice to prevent potential mechanical failure or surface damage.
The recalled product
- Product
- 8MM,BLACK DIAMOND MICRO FORCEPS; 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: 470033-04
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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