da Vinci SP Instrument Arm Drape — Class II medical device recall Z-1906-2020
Terminated recall by Intuitive Surgical, Inc., reported 2020-05-13, distributed in AL, CA, FL, HI, IL, MD, MN, NC…. The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
| Recall number | Z-1906-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-10-25 |
| Classified | 2020-05-06 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2024-04-05 |
| Distributed | AL, CA, FL, HI, IL, MD, MN, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA |
| Countries outside the US | KR |
| Quantity | 1,818 pouches |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00886874113486 |
| Model numbers | 430013-12 |
Product
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Reason for recall
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
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-1906-2020. 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.