Z-0258-2008

Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical...

Name: Z-0258-2008 Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical...
Creator: Intuitive Surgical, Inc.
Published: 2007-04-13
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2007-04-13 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03... on 2007-04-13. The reason FDA records is "Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0258-2008
Status: Terminated
Initiated: 2007-04-13
Posted: 2008-01-24
Terminated: 2008-08-01
Recalling firm: Intuitive Surgical, Inc.
Product: Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, Inc., Sunnyvale, CA
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)
Root cause tag: design
FDA root cause: Device Design
Action: On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.
Quantity in commerce: 1,136 units
Distribution: Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)
Product codes and lots: All instruments manufactured till 03/21/07

Product code NAY

K061260Class IIIntuitive Surgical Endowrist Pk Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. / cleared 2006-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)