Intuitive Surgical Recalls Tip Cover Accessories for Labeling Clarification
Intuitive Surgical is recalling 50,000 boxes of Tip Cover Accessories for the da Vinci Surgical System to clarify existing labeling and related cautions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a labeling clarification rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 50,000 boxes of 10 Tip Cover Accessories, 8 MM, MCS, for the da Vinci Surgical System. The recall is being conducted to clarify existing labeling and related cautions for the product.
The affected tip covers are used in conjunction with 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the instrument so that frequency response (FR) energy is only available at the scissors blades. The recall includes model numbers 400180-10 and prior versions 400180-01 through 400180-09.
The products were distributed worldwide, including the United States, Australia, Austria, Belgium, China, and numerous other countries. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
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 (7)
- Model numbers: 400180-10 and prior versions 400180-01
- 400180-02
- 400180-03
- 400180-04
- 400180-05
- 400180-06. 400180-07
- 400180-08 and 400180-09.
Distribution
Distributed nationwide across the United States.
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