Food, drugs, devices › Intuitive Surgical, Inc.

Device recall: da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

FDA enforcement event 92418 · Class II · initiated 12 Jun 2023 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordSunnyvale, CA

FDA enforcement event 92418 is a device recall by Intuitive Surgical, Inc. of Sunnyvale, CA, initiated 12 Jun 2023 and classified Class II, with 1 product record.

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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. 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

"Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected."

Distribution

"Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2059-2023	da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12	46,033	Class II	Ongoing	12 Jul 2023

Context

88%of 2023 device events are Class II917 events that year

1product record 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: "Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected."

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 - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY,…"

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.