Intuitive Surgical, Inc. received an enforcement report from the US Food and Drug Administration regarding the da Vinci X and da Vinci Xi Surgical System, Model/Catalog Number: IS4000; IS4200. The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument. The recall was initiated due to manipulator containing screws within the arm sub-assembly that may be susceptible to breaking.

The product quantity affected is 2781 units. The recall number is Z-2046-2026. Code Information includes Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 and UDI: 00886874114216 FDA Medical Device Listing Number: D295931.

The recall is classified as Class II. The event ID is 98564. The recall was voluntary and firm initiated.

The product type is Devices. The initial firm notification of consignee or public was by letter. The recall status is ongoing.

The distribution pattern is worldwide, including U.S. nationwide distribution and countries such as Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom. The recalling firm is Intuitive Surgical, Inc. The recall initiation date is April 2, 2026. The center classification date is May 1, 2026.