da Vinci Xi EndoWrist Stapler 45 Reload Blue — Class II medical device recall Z-2380-2018
Terminated recall by Intuitive Surgical, Inc., reported 2018-07-18. Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and
| Recall number | Z-2380-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-04-23 |
| Classified | 2018-07-06 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-07-15 |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IT, JP, KR, LU, NL, NO, QA, SA, SE, SG, TR, TW |
| Quantity | 7,337 |
| UPC / GTIN / UDI-DI | 00886874112878 |
| Model numbers | 48645B-03 |
| Expiration dates | 2017-10-14 |
Product
da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Reason for recall
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
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-2380-2018. 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.