Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 8mm Maryland 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, but the source text explicitly states no injuries or illnesses have been reported, and the hazard is theoretical (potential for degradation/wear), which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8mm Maryland Bipolar Forceps intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall involves 5 to 9 units distributed in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts. The affected instruments are identified by part number 470172-05 and are manufactured with white colored housings.
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 source text does not report any specific injuries, illnesses, or deaths associated with this recall.
Healthcare facilities and users should stop using the affected instruments and contact Intuitive Surgical for further instructions on reprocessing or replacement.
The recalled product
- Product
- 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
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: 470172-05
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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