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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96345

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

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Event summary

Timeline bucket
February 26, 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

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

Z-1325-2025
Recall number
Z-1325-2025
Initiated
February 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
439 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Code information

UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the country of South Korea.

Field note

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