FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
- Recall number
- Z-2380-2018
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
- Status
- Terminated
- Initiated
- 2018-04-23
- Posted
- not on file
- Terminated
- 2020-07-15
- Reason
- Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
- Root cause
- Nonconforming Material/Component
- Action
- Intuitive Surgical, Inc. (ISI) conducted the recall and notified customers via letter "Field Safety Notice Urgent Medical Device Notification" sent the week of April 23, 2018. The letter notified customers of the recall, reason for field action, risk to health, affected products, Actions to be taken by the Customer/User, Actions to be taken by Intuitive Surgical, and Further Information and Support: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: "North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. "Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8AM to 6 PM CET) or ics@intusurg.com "South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) "Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST).
- Quantity
- 7337
- Distribution
- U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
- Lot, serial or model codes
- UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020
- 510(k) numbers
- ["K140553"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28