Patient Side Cart — Class II medical device recall Z-1262-2023
Ongoing recall by Intuitive Surgical, Inc., reported 2023-03-22, distributed nationwide. Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surge
| Recall number | Z-1262-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2023-01-24 |
| Classified | 2023-03-16 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, GB |
| Quantity | 9 |
| UPC / GTIN / UDI-DI | 00886874110720, 00886874115404 |
| Serial numbers | 00886874110720, 00886874115404, 372054, 380620, 409962, 425439, 547953, 557322, 575093, 663693, 668080, IS4000, IS4200, SK0110, SK0744, SK0753/380652, SK0991, SK1402, SK2332, SL0069, SL0379 |
| Model numbers | 380620, 380652, IS4000, IS4200 |
Product
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
Reason for recall
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1262-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.