The da Vinci Xi and X surgical systems — Class II medical device recall Z-0275-2022
Terminated recall by Intuitive Surgical, Inc., reported 2021-12-01, distributed nationwide. Incorrect expiration date on its package labeling (shipper box and inner carton label).
| Recall number | Z-0275-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2021-09-21 |
| Classified | 2021-11-23 |
| Reported by FDA | 2021-12-01 |
| Terminated | 2024-01-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00886874112199 |
| Lot numbers | DM4210309 |
| Model numbers | 470015, 470015-07 |
Product
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.
Reason for recall
Incorrect expiration date on its package labeling (shipper box and inner carton label).
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-0275-2022. 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.