Z-0433-2015Class II

8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic...

Name: Z-0433-2015 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic...
Creator: Intuitive Surgical, Inc.
Published: 2014-11-03
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-11-03 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments on 2014-11-03. FDA classified it as Class II and gives the reason as "Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0433-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-03
Posted: 2014-11-25
Terminated: 2015-02-03
Recalling firm: Intuitive Surgical, Inc.
Product: 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall. Customers are to take the following actions: 1. Ensure that all affected personnel are aware of the information. 2. Identify affected product in their possession 3. Contact ISI rep for replacement. 4. Complete and return the attached Acknowledgement From. Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or [email protected].
Quantity in commerce: 5-9 units - total all devices
Distribution: US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
Product codes and lots: Part number: 470172-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0433-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0427-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0428-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0429-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0430-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0431-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0432-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0433-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0434-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0435-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0436-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0437-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0438-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0439-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0440-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0441-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0442-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0443-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0444-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0445-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0446-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0447-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25
Z-0448-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

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)