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 hazard involves a potential failure to maintain a sterile field during surgery, which poses a risk of harm even though specific injuries are not reported in the text.
Plain-English summary
Intuitive Surgical, Inc. is recalling specific lots of the KIT, DISPOSABLE ACCESSORY, 3ARM, IS3000, 5 PACK Instrument Arm Drapes. The intended use of these drapes is 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. A total of 92,390 instrument drapes are affected. The products were distributed worldwide, including the United States, Australia, Spain, India, Italy, and Saudi Arabia.
The affected part number is 420290-03. Specific lot numbers include D120735, D120745, D120815, D120815A, D120885, D120895, D120905, D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, and D121215. Users should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- KIT,DISPOSABLE ACCESSORY,3ARM,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.
- 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 (20)
- Part number: 420290-03 Lot numbers: D120735
- D120745
- D120815
- D120815A
- D120885
- D120895
- D120905 D120945
- D120955
- D120955A
- D120965
- D121025
- D121035
- D121045
- D121075
- D121075A
- D121095
- D121155
- D121165
- D121165A
- D121215.
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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