- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Affected products (lot / model / serial)
- Lot Code: UDI: 00886874114216 FDA Medical Device Listing Number: D531324 See attachment Affected Product List UDI: 00886874114216 FDA Medical Device Listing Number: D295931 See attachment Affected Product List
- Units affected
- 2781
- Distribution pattern
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of 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.
- Firm location
- Sunnyvale, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2046-2026
- Recall initiated
- April 2, 2026
- FDA classification date
- May 1, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98564
- Last updated on HTM Vibe
- July 24, 2026