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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71285

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

Open FDA event record

Event summary

Timeline bucket
May 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.

Z-1812-2015
Recall number
Z-1812-2015
Initiated
May 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
2,436 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.

Code information

version 420343-01 and 420323-02, all lots

Distribution pattern

Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.