da Vinci SP Camera — Class II medical device recall Z-2131-2020
Ongoing recall by Intuitive Surgical, Inc., reported 2020-06-03, distributed nationwide. Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may af
| Recall number | Z-2131-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2019-08-19 |
| Classified | 2020-05-26 |
| Reported by FDA | 2020-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 305 units |
| UPC / GTIN / UDI-DI | 00886874114384 |
| Model numbers | 430060-33 |
Product
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Reason for recall
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
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-2131-2020. 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.