Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (difficulty engaging) rather than a direct safety risk like contamination or failure, fitting the criteria for a moderate severity recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling specific lots of the Instrument Arm Drapes (Part number 420258-01). The affected lots are D120755, D120755A, and D120825. The total quantity involved is 92,390 instrument drapes.
The recall is being conducted because the sterile adaptor on these specific lots may have difficulty engaging an instrument. The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
The affected products were distributed worldwide, including the United States, Australia, Spain, India, Italy, and Saudi Arabia. Users of these products should contact Intuitive Surgical, Inc. for further instructions on how to proceed.
The recalled product
- Product
- KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 92,390
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 (3)
- Part number: 420258-01 Lot numbers: D120755
- D120755A
- D120825.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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