Food, drugs, devices › Intuitive Surgical, Inc.

Device recall: Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-1

FDA enforcement event 72036 · Class II · initiated 8 Aug 2015 · status Terminated · terminated 3 Dec 2015

DeviceVoluntary: Firm initiated9 product recordsSunnyvale, CA

FDA enforcement event 72036 is a device recall by Intuitive Surgical, Inc. of Sunnyvale, CA, initiated 8 Aug 2015 and classified Class II, with 9 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 3 Dec 2015. 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

"In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position."

Distribution

"Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2750-2015	Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room…	8217 total units	Class II	Terminated	16 Sep 2015
Z-2751-2015	Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment…	17617 total units	Class II	Terminated	16 Sep 2015
Z-2752-2015	Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for…	2410 total units	Class II	Terminated	16 Sep 2015
Z-2753-2015	Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic…	89 total units	Class II	Terminated	16 Sep 2015
Z-2754-2015	Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for…	6309 total units	Class II	Terminated	16 Sep 2015
Z-2755-2015	Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for…	15,834 total units	Class II	Terminated	16 Sep 2015
Z-2756-2015	Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for…	13,644 total units	Class II	Terminated	16 Sep 2015
Z-2757-2015	Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for…	3698 total units	Class II	Terminated	16 Sep 2015
Z-2758-2015	Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment…	21,684 total units	Class II	Terminated	16 Sep 2015

Context

91%of 2015 device events are Class II1,153 events that year

9product 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: "In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position."

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 Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 3 Dec 2015. "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.