Exact FDA event identifier

Event 74188

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 09, 2016
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

2 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 2

SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.

Z-1836-2016

Recall number: Z-1836-2016
Initiated: May 09, 2016
Classification: Class II
Status: Terminated
Recalling firm: Intuitive Surgical, Inc.
Quantity: 46, 191 boxes - total both sizes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulates

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

Code information

All lots

Distribution pattern

Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

device · product 2 of 2

SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure.

Z-1837-2016

Recall number: Z-1837-2016
Initiated: May 09, 2016
Classification: Class II
Status: Terminated
Recalling firm: Intuitive Surgical, Inc.
Quantity: 46,191 boxes total - both sizes