CLASS II ONGOING Device recall · Reported 6 Nov 2019 · FDA Enforcement Report

EndoWrist Suction Irrigator, Single Use Instrument recalled

Intuitive Surgical is recalling EndoWrist Suction Irrigator, Single Use Instrument, distributed nationwide in the US. The recall was initiated on 4 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

Quantity recalled3108 units (518 boxes of 6 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-0249-2020
FDA event ID: 81073
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Jun 2018
FDA classified: 30 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

4 Jun 2018	Recall initiated by company
30 Oct 2019	Classified by FDA	+513 days
6 Nov 2019	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

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Product as listed by the FDA

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Where it was distributed

Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

Nationwide

Questions about this recall

Is EndoWrist Suction Irrigator, Single Use Instrument recalled?

Yes. Intuitive Surgical recalled EndoWrist Suction Irrigator, Single Use Instrument on 4 Jun 2018. The recall is Class II and its status is Ongoing. Recall number Z-0249-2020.

Why was it recalled?

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Which lots are affected?

Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

Where was it sold?

Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

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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