daVinci XI Sureform 60 reload — Class II medical device recall Z-1890-2020
Ongoing recall by Intuitive Surgical, Inc., reported 2020-05-13, distributed nationwide. The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads
| Recall number | Z-1890-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2019-07-01 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, LU, NL, NO |
| Quantity | 22,752 reloads |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00886874113844 |
| Lot numbers | T10180511, T10180718, T10180821, T10180822, T10180906, T10180913, T10180925, T10181008, T10190204, T10190208, T10190213, T11180816, T11190219 |
| Model numbers | 48360G-08 |
Product
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
Reason for recall
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
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-1890-2020. 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.