Food, drugs, devices › Intuitive Surgical, Inc.

Device recall: da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry

FDA enforcement event 65168 · Class II · initiated 6 May 2013 · status Terminated · terminated 15 Apr 2014

DeviceVoluntary: Firm initiated2 product recordsSunnyvale, CA

FDA enforcement event 65168 is a device recall by Intuitive Surgical, Inc. of Sunnyvale, CA, initiated 6 May 2013 and classified Class II, with 2 product records.

FDA defines Class II as 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 15 Apr 2014. Initiation: voluntary: firm initiated. Intuitive Surgical, Inc. has 105 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Intuitive Surgical, Inc., Sunnyvale, CA.

Reason for recall

"Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262)."

Distribution

"Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1463-2013	da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,	2101 consignees	Class II	Terminated	12 Jun 2013
Z-1464-2013	da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments	2101 consignees	Class II	Terminated	12 Jun 2013

Context

90%of 2013 device events are Class II1,236 events that year

2product records in this eventfirm median: 1

105events on this register for the firm

Other enforcement events for Intuitive Surgical, Inc.

Initiated	Product (first record)	Type	Class	Records
24 Apr 2026	Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product De	Device	Class II	1
22 Apr 2026	Da Vinci ASSY, PSS, SP1098, Part Number: 380601	Device	Class II	1
2 Apr 2026	Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200	Device	Class II	1
11 Mar 2026	Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06	Device	Class I	1
30 Dec 2025	da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45	Device	Class II	1
15 Dec 2025	da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,	Device	Class II	1
9 Dec 2025	Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/	Device	Class II	2
9 Dec 2025	Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissor	Device	Class II	4
4 Dec 2025	Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A	Device	Class II	1
17 Nov 2025	Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.	Device	Class II	1

All 105 events for Intuitive Surgical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262)."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.