Intuitive Surgical Recalls 8mm MEGA SUTURECUT ND Instruments
Intuitive Surgical is recalling 509 units of 8mm MEGA SUTURECUT ND instruments due to potential surface degradation and accelerated mechanical wear.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential mechanical wear and surface degradation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm MEGA SUTURECUT ND instruments. 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 470309-04.
The recall is issued because deviations in reprocessing steps from the stated instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. The affected units were distributed in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities should stop using the affected instruments and contact Intuitive Surgical for further instructions regarding the recall.
The recalled product
- Product
- 8MM, MEGA SUTURECUT ND; 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
- 470309-04
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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