Food, drugs, devices › Intuitive Surgical, Inc.

Device recall: Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

FDA enforcement event 98200 · Class II · initiated 17 Nov 2025 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordSunnyvale, CA

Intuitive Surgical, Inc. (Sunnyvale, CA) initiated this device recall on 17 Nov 2025; FDA lists 1 product record under event 98200, 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. 85% of the 945 device enforcement events initiated in 2025 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

"An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor."

Distribution

"US distribution: LA, MA, NY, PA, TX, and VA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1428-2026	Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.	12	Class II	Ongoing	25 Feb 2026

Context

85%of 2025 device events are Class II945 events that year

1product record in this eventfirm median: 1

105events on this register for the firm

Other enforcement events for Intuitive Surgical, Inc.

Initiated	Product (first record)	Type	Class	Records
24 Apr 2026	Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product De	Device	Class II	1
22 Apr 2026	Da Vinci ASSY, PSS, SP1098, Part Number: 380601	Device	Class II	1
2 Apr 2026	Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200	Device	Class II	1
11 Mar 2026	Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06	Device	Class I	1
30 Dec 2025	da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45	Device	Class II	1
15 Dec 2025	da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,	Device	Class II	1
9 Dec 2025	Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/	Device	Class II	2
9 Dec 2025	Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissor	Device	Class II	4
4 Dec 2025	Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A	Device	Class II	1
7 Nov 2025	Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS	Device	Class II	1

All 105 events for Intuitive Surgical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor."

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 distribution: LA, MA, NY, PA, TX, and VA."

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.