Intuitive Surgical, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
All instruments manufactured till 03/21/07
Products Sold
All instruments manufactured till 03/21/07
Intuitive Surgical, Inc. is recalling Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S S due to Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI
Page updated: Jan 10, 2026