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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98200

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 17, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Intuitive Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1428-2026
Recall number
Z-1428-2026
Initiated
November 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
12

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
error event following the release of a software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1

Distribution pattern

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