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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in surgical procedures where a failure to maintain a sterile field or engage instruments poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling specific lots of the Instrument Arm Drape (Part number: 420256-01). The affected lots are D120745, D120755, D120835, and D120865. A total of 92,390 instrument drapes were distributed worldwide, including in the United States, Australia, Spain, India, Italy, and Saudi Arabia.
The recall was initiated 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.
Healthcare facilities and users should stop using the affected lots and contact Intuitive Surgical for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- KIT,DISPOSABLE ACCESSORY,3ARM,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.
- 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 (4)
- Part number: 420256-01 Lot numbers: D120745
- D120755
- D120835
- D120865.
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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