Recall Register

Food, drugs, devices › Intuitive Surgical, Inc.

Device recall: da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

FDA enforcement event 98048 · Class II · initiated 21 Aug 2024 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordSunnyvale, CA

Intuitive Surgical, Inc. (Sunnyvale, CA) initiated this device recall on 21 Aug 2024; FDA lists 1 product record under event 98048, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Intuitive Surgical, Inc. has 105 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Intuitive Surgical, Inc., Sunnyvale, CA.

Reason for recall

"Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure"

Distribution

"US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT."

Product records

Recall numberProductQuantityClassStatusReport date
Z-0964-2026da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40144Class IIOngoing31 Dec 2025

Context

87%of 2024 device events are Class II970 events that year
1product record in this eventfirm median: 1
105events on this register for the firm

Other enforcement events for Intuitive Surgical, Inc.

InitiatedProduct (first record)TypeClassRecords
24 Apr 2026Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product DeDeviceClass II1
22 Apr 2026Da Vinci ASSY, PSS, SP1098, Part Number: 380601DeviceClass II1
2 Apr 2026Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200DeviceClass II1
11 Mar 2026Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06DeviceClass I1
30 Dec 2025da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45DeviceClass II1
15 Dec 2025da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,DeviceClass II1
9 Dec 2025Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/DeviceClass II2
9 Dec 2025Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved ScissorDeviceClass II4
4 Dec 2025Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/ADeviceClass II1
17 Nov 2025Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.DeviceClass II1

All 105 events for Intuitive Surgical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.