Z-0340-2023Class II

INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm...

Name: Z-0340-2023 INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm...
Creator: Intuitive Surgical, Inc.
Published: 2022-10-07
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2022-10-07 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of 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... on 2022-10-07. FDA classified it as Class II and gives the reason as "Potential staple deployment failure and device fragment generation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0340-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-07
Posted: 2022-11-30
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
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Potential staple deployment failure and device fragment generation
Root cause tag: manufacturing process
FDA 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: [email protected]
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0340-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0340-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-30

Product code NAY

K211997Class II8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc. / cleared 2021-12-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)