Intuitive Surgical, Inc. 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.
Products Sold
The 8mm EndoWrist Bipolar Maryland Instrument is manufactured in lots, and traceability is maintained for each lot. A two digit unique identifier is added to the lot number label on the instruments, and programming records are traceable to these identifiers. The following 8 instruments from lot # 0503051 are affected: 0503051 66, 0503051 67, 0503051 68, 0503051 69, 0503051 70, 0503051 71, 0503051 72, and 0503051 73.
Intuitive Surgical, Inc. is recalling 8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by due to The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.
Recommended Action
Per FDA guidance
The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.
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
FL, IN, LA, MN, NH, NJ, NY, NC, TN, TX
Page updated: Jan 10, 2026