CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report

Da Vinci Single-Site Wristed Needle Driver recalled

Intuitive Surgical is recalling Da Vinci Single-Site Wristed Needle Driver, distributed in 14 states. The recall was initiated on 6 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

Quantity recalled317 units

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-0406-2024
FDA event ID: 93301
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Oct 2023
FDA classified: 28 Nov 2023
Reported: 6 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

6 Oct 2023	Recall initiated by company
28 Nov 2023	Classified by FDA	+53 days
6 Dec 2023	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

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Product as listed by the FDA

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Where it was distributed

US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

California Colorado Florida Idaho Illinois Michigan Mississippi New Jersey New York Oregon Puerto Rico South Carolina Tennessee Texas

Questions about this recall

Is Da Vinci Single-Site Wristed Needle Driver recalled?

Yes. Intuitive Surgical recalled Da Vinci Single-Site Wristed Needle Driver on 6 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0406-2024.

Why was it recalled?

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Which lots are affected?

UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

Where was it sold?

US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

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.

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22 Jul 2026Device	CLASS II	da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
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