Z-2750-2015Class II

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

Name: Z-2750-2015 Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13...
Creator: Intuitive Surgical, Inc.
Published: 2015-08-08
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-08-08 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of 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... on 2015-08-08. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2750-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-08
Posted: 2015-09-10
Terminated: 2015-12-03
Recalling firm: Intuitive Surgical, Inc.
Product: 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 environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Product code: NAY System, Surgical, Computer Controlled Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures. 2. Replace any instrument that shows signs of damage and contact Intuitive Surgical Customer Service. 3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual. If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: [email protected] Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.
Quantity in commerce: 8217 total units
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
Product codes and lots: Model numbers: 428050-12. 428050-13 and 428050-14; all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2750-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2750-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2751-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2752-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2753-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2754-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2755-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2756-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2757-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2758-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)