da Vinci SP surgical system — Class II medical device recall Z-2260-2020
Terminated recall by Intuitive Surgical, Inc., reported 2020-06-10, distributed in AL, IL, MD, MN, NJ, NY, OR, TN…. Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument ti
| Recall number | Z-2260-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2019-04-01 |
| Classified | 2020-06-03 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-12-16 |
| Distributed | AL, IL, MD, MN, NJ, NY, OR, TN, TX |
| Countries outside the US | KR |
| Quantity | 17 |
| Reason classes | software |
| Serial numbers | SP0022, SP0023, SP0024, SP0025, SP0026, SP0027, SP0028, SP0029, SP0030, SP0031, SP0032, SP0034, SP0035, SP0036, SP0037, SP0038, SP0039 |
Product
da Vinci SP surgical system
Reason for recall
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
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-2260-2020. 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.