CLASS II Device recall · Reported 8 Jun 2022 · FDA Enforcement Report

Davinci | Energy SynchroSeal da Vinci X' da Vinci Xi' recalled

Intuitive Surgical is recalling Davinci | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument, distributed nationwide in the US. The recall was initiated on 3 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00886874117309. All lots

Quantity recalled7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed

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-1210-2022
FDA event ID: 89641
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Completed
Recall initiated: 3 Mar 2022
FDA classified: 31 May 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

3 Mar 2022	Recall initiated by company
31 May 2022	Classified by FDA	+89 days
8 Jun 2022	Published in enforcement report	+8 days

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

Reason for recall

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Where it was distributed

Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Which lots are affected?

UDI: 00886874117309. All lots

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 89641

This product is part of a recall event; the main page for the event is Vessel Sealer Extend, Single-Use Instrument EndoWrist recalled.

Reported	Class	Recall	Company	Reason	Where
8 Jun 2022	CLASS II	Vessel Sealer Extend, Single-Use Instrument EndoWrist recalled	Intuitive Surgical	Packaging Defects	Nationwide

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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide