da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 — FDA record Z-1355-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Reason
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
Classification
Class II
Recalling firm
Intuitive Surgical, Inc.
Quantity
47
Agency-reported status
Ongoing
Source record identifier
Z-1355-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityUDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367, SQ0368, SQ0375, SQ0377, SQ0379, SQ0380, SQ0386, SQ0387, SQ0389, SQ0394, SQ0395, SQ0398, SQ0401, SQ0404, SQ0412, SQ0413, SQ0415, SQ0419, SQ0420, SQ0422, SQ0425, SQ0427, SQ0428, SQ0432, SQ0433, SQ0436, SQ0443, SQ0447, SQ0448, SQ0451, SQ0454, SQ0457, SQ0458, SQ0462, SQ0464, SQ0469, SQ0470, SQ0662, SQ0727, SQ0740, SQ0761

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Feb 18, 2026
Recall initiation date
Dec 30, 2025
Center classification date
Feb 12, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records