CLASS II ONGOING Device recall · Reported 7 Dec 2022 · FDA Enforcement Report

Intuitive Da Vinci Xi SureForm 30 Curved-Tip Stapler Da Vinci Xi|X recalled

Intuitive Surgical is recalling Intuitive Da Vinci Xi SureForm 30 Curved-Tip Stapler Da Vinci Xi|X, distributed in 24 states. The recall was initiated on 7 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0340-2023
FDA event ID: 91080
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Oct 2022
FDA classified: 30 Nov 2022
Reported: 7 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

7 Oct 2022	Recall initiated by company
30 Nov 2022	Classified by FDA	+54 days
7 Dec 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential staple deployment failure and device fragment generation

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Arizona California Colorado Florida Illinois Indiana Louisiana Massachusetts Maryland Michigan Minnesota North Carolina Nevada New York Ohio Oklahoma Pennsylvania South Carolina Tennessee Texas

Questions about this recall

Is Intuitive Da Vinci Xi SureForm 30 Curved-Tip Stapler Da Vinci Xi|X recalled?

Yes. Intuitive Surgical recalled Intuitive Da Vinci Xi SureForm 30 Curved-Tip Stapler Da Vinci Xi|X on 7 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0340-2023.

Why was it recalled?

Potential staple deployment failure and device fragment generation

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Intuitive Surgical

All 256

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
1 Jul 2026Device	CLASS II	Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	49 states
13 May 2026Device	CLASS I	Intuitive SureForm 30 Gray Reloads Reference Numbers recalled	Intuitive Surgical	Other	49 states
13 May 2026Device	CLASS II	Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled	Intuitive Surgical	Device Malfunction	Nationwide

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