Agency classClass IIOur severity:High FDA (Devices)·Z-1837-2016·Announced 2016-06-08

Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where particulates could be introduced into a patient's body during surgery. While the source text does not report specific injuries or illnesses, the potential for harm in a surgical context aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Xi Surgical System cannula seals (part number 470380, model numbers 470380-04, 470380-05, and 470380-06). The recall involves 46,191 boxes of the product, which are distributed worldwide across numerous countries including the United States, Australia, and various European and Asian nations.

The recall is being issued due to a potential for particulates in the insufflation stopcocks on the cannula seals. According to the source text, these particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure. The seals are used to maintain insufflation when the cannula is empty and when instruments are inserted.

This recall affects all lots of the affected model numbers. The source text does not specify specific dates of distribution or identify specific hospitals or facilities affected, but notes the global distribution pattern. Healthcare facilities should contact Intuitive Surgical for instructions on how to handle the recalled product.

The recalled product

Product: SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the…
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Instrument
Hazard: contamination
foreign-object
Affected units: 46,191

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Intuitive Surgical, Inc.

See all →

Moderate
da Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
Severe
Da Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
High
Da Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
High
da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
Severe
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13

Same hazard · contamination