Intuitive Surgical Recalls 8mm Fenestrated Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 509 units of 8mm Fenestrated Bipolar Forceps because deviations in reprocessing steps can cause 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. The hazard involves mechanical wear and surface degradation due to reprocessing deviations, which is a significant but non-critical defect without reported injuries or fatalities.
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm Fenestrated Bipolar Forceps (Part number 470205-05). These instruments are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments and are manufactured with white colored housings for the 8mm da Vinci Xi (IS4000) Surgical System.
The recall is issued 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 devices were distributed in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities that have received these instruments should stop using them and contact Intuitive Surgical for further instructions on the recall.
The recalled product
- Product
- 8MM FENESTRATED BIPOLAR 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 470205-05
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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