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 is classified as FDA Class II, and the defect poses a risk of harm (failure to maintain sterile field) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling specific lots of the KIT, DISPOSABLE ACCESSORY, 4ARM, IS3000, 5 PACK Instrument Arm Drapes. These products are intended to protect equipment from contamination and maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
The recall is due to a manufacturing defect where the sterile adaptor may have difficulty engaging an instrument. The affected lots were distributed worldwide, including the United States, Australia, Spain, India, Italy, and Saudi Arabia. A total of 92,390 instrument drapes are involved in this recall.
Healthcare facilities and users should stop using the affected lots and contact Intuitive Surgical for further instructions. The specific lot numbers affected are D120795, D120795A, D120805, D120815, D120875, D120885, D120885A, D120935, D120935A, D120945, D121015, D121025, D121025A, D121105, D121105A, and D121355A.
The recalled product
- Product
- KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 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
- 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 (10)
- Part number: 420291-03 Lot numbers: D120795
- D120795A
- D120805
- D120815
- D120875
- D120885
- D120885A
- D120935
- D120935A
- D120945 D121015 D121025 D121025A D121105 D121105A D121355A
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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