Data Foundry

Medical device recalls 2020

The da Vinci SP surgical system is made of three main components: the… — Class II medical device recall Z-0845-2020

Terminated recall by Intuitive Surgical, Inc., reported 2020-02-05, distributed in MN, NY, OH, PA. The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when

Recall numberZ-0845-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated2018-10-23
Classified2020-01-24
Reported by FDA2020-02-05
Terminated2022-01-21
DistributedMN, NY, OH, PA
Quantity5 pscs
Model numbers1098

Product

The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.

Reason for recall

The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

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-0845-2020. 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.