CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

Da Vinci X/Xi Large Clip Applier recalled by Intuitive Surgical

Intuitive Surgical is recalling Da Vinci X/Xi Large Clip Applier, distributed nationwide in the US. The recall was initiated on 1 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Model Number/UDI Number Da Vinci X/Xi Large Clip Applier / 470230 / 00886874112380 Da Vinci X/Xi Medium-Large Clip Applier / 470327 / 00886874112465 Da Vinci X/Xi Small Clip Applier / 470401 / 00886874112670 Serial Numbers: All

Quantity recalled90,628 Clip appliers

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-1460-2022
FDA event ID: 90332
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Jul 2022
FDA classified: 25 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Jul 2022	Recall initiated by company
25 Jul 2022	Classified by FDA	+24 days
3 Aug 2022	Published in enforcement report	+9 days

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

Reason for recall

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Product as listed by the FDA

Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Which lots are affected?

Model/Model Number/UDI Number Da Vinci X/Xi Large Clip Applier / 470230 / 00886874112380 Da Vinci X/Xi Medium-Large Clip Applier / 470327 / 00886874112465 Da Vinci X/Xi Small Clip Applier / 470401 / 00886874112670 Serial Numbers: All

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

Other products in this recall event

1 other product · FDA event 90332

This product is part of a recall event; the main page for the event is Da Vinci S/Si Large Clip Applier recalled by Intuitive Surgical.

Reported	Class	Recall	Company	Reason	Where
3 Aug 2022	CLASS II	Da Vinci S/Si Large Clip Applier recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide

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