The FDA announced on 2019-08-19 that Intuitive Surgical, Inc. is recalling da Vinci SP Cameras (Model Number 430060-33) due to residual soil hazards. The agency said the issue may affect image quality or cause patient sensitization if soil contacts the patient.
How to tell if you have it
- Brand: Intuitive Surgical
- Product: da Vinci SP Camera
- Model Number: 430060-33
- PN: 430060-33
- UDI Number: 00886874114384
- All serial numbers
The hazard
Some cameras had residual soil adhered to the tip after reprocessing, which may affect image quality. If soil contacts a patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging. Additionally, retained inert epoxy pieces could cause scar tissue formation.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since 2017-06-01. Recent recalls include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (2026-04-24) and the Intuitive Surgical Da Vinci Surgical System Recall (2026-04-22). Other recent recalls of similar products include the Olympus Single Use Sphincterotome V Recall (2026-01-07) and the Olympus Disposable Triple Lumen Sphincterotome Recall (2026-01-07).