INSTRUMENT ARM DRAPE — Class II medical device recall Z-1949-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-07-08, distributed nationwide. Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Dr
| Recall number | Z-1949-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-06-16 |
| Classified | 2015-07-01 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CZ, DE, ES, FR, GB, GR, IL, IN, IT, JP, KR, NL, NO, QA, SA, SE, SG, TR |
| Quantity | 310 |
| Lot numbers | 470015-05, 470015-06 |
| Model numbers | IS4000 |
Product
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason for recall
Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.
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-1949-2015. 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.