FDA Device recall Z-2131-2020
da Vinci SP Camera
- FDA Device
- Class II
- ongoing
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of da Vinci SP Camera by Intuitive Surgical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2131-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-08-19 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Reason
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.
Identifiers
| code_info | Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2131-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.