Da Vinci ASSY — Class II medical device recall Z-2521-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-07-01, distributed nationwide. Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a s
| Recall number | Z-2521-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2026-04-22 |
| Classified | 2026-06-22 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CN, CZ, DE, DK, ES, FR, GB, GR, HK, IE, IL, IT, JP, KR, PL, RO, SA, SE, TR, TW |
| Quantity | 454 |
| UPC / GTIN / UDI-DI | 00886874114605 |
| Serial numbers | 10003059, 10003509, 10003510, 10008062, 10009706, 10009707, 10012962, 10012963, 10020705, 10020729, 10031144, 10031145, 10035476, 10036960, 10036961, 10043635, 10054478, 10056518, 10065786, 10069899, 10072852, 10072853, 10076490, 10080929, 10087446 and 429 more |
| Model numbers | 380601 |
Product
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Reason for recall
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
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-2521-2026. 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.