Intuitive Surgical, Inc.: INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

Recall number

Z-0340-2023

Recalling firm

Intuitive Surgical, Inc.

Product

INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

Status

Open, Classified

Initiated

2022-10-07

Posted

2022-11-30

Terminated

not on file

Reason

Potential staple deployment failure and device fragment generation

Root cause

Nonconforming Material/Component

Action

On 10/07/2022, Intuitive Surgical communicated an "Urgent Product Safety Notice" email to "STOP USE of da Vinci Xi 8mm SureForm 30 Stapler Instruments (488530-10) and Reloads (48230M-02, 48230W-02, 48230B-02)" and informing customers that there is a potential to transect targeted tissue without stapler formation that could result in bleeding and potential to generate fragments when using these products. On or about 10/25/2022, the firm sent an "Urgent Medical Device Removal" Letter via FedEx that informed their customers of the STOP USE. Customers are instructed to: Locate and return all affected products, as listed above, in their inventory via the standard RMA process by calling Intuitive Customer Service at (800) 876-1310, Option 3, 4 AM to 5 PM PST. If they have shared these products with other sites, make sure appropriate staff at that site receive and understanding this notification so that they locate and return their affected product. Customers may continue to use the da Vinci 12mm SureForm 45/60 instruments and reloads, as well as EndoWrist Stapler instruments and reloads, as these instruments are not impacted by this issue and use a different technology to effect stapler formation. For questions or further information: Contact their Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com

Quantity

160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads

Distribution

U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. O.U.S.: None

Lot, serial or model codes

Model Name / Model Number / UDI-DI Code: Da Vinci Xi 8mm SureForm 30 instruments 488530-10 10886874121723 Da Vinci Xi 8mm SureForm 30 Grey Reload 48230M-02 10886874121938 Da Vinci Xi 8mm SureForm 30 White Reload 48230W-02 10886874121921 Da Vinci Xi 8mm SureForm 30 Blue Reload 48230B-02 10886874121914 All Serial Numbers

510(k) numbers

["K211997"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

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

Copy