da Vinci SP Instrument Arm Drape — Class II medical device recall Z-2722-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-07-22, distributed nationwide. Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the d
| Recall number | Z-2722-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2025-05-12 |
| Classified | 2026-07-10 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, DK, ES, FR, GB, HK, IE, IT, JP, KR, SE, TW |
| Quantity | 11,113 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00886874113486 |
| Lot numbers | 1084LA0300, 1124LA0200, 1134LA0700, 1144LA0500, 1274LA0400, 1274LA0500, 1324LA0300, 1394LA0100, 2124LA0400, 2284LA0100, 2294LA0200, 2354LA0500, 3074LA0500, 3164LAA800, 3224LA0500, 3324LA0500, 3374LA0400, 3424LA0200, 4084LA0500, 4124LA0600, 4144LA1300, 4154LA0400, 4284LA0800, 4294LA0700, 5264LA0700, 6164LA0800, 6324LA0200, 7144LA0500, 7154LA0200 |
| Model numbers | 430013-13, 430013-15 |
Product
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Reason for recall
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
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-2722-2026. 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.