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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69283

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

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Event summary

Timeline bucket
September 18, 2014
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

EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Z-0074-2015
Recall number
Z-0074-2015
Initiated
September 18, 2014
Classification
Class II
Status
Terminated
Recalling firm
Intuitive Surgical, Inc.
Quantity
1,034 Devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

Code information

EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.

Distribution pattern

US Nationwide Distribution.