Z-1906-2020Class II

da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

Name: Z-1906-2020 da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Creator: Intuitive Surgical, Inc.
Published: 2018-10-25
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-10-25 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch on 2018-10-25. FDA classified it as Class II and gives the reason as "The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier". 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-1906-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-25
Posted: 2020-05-06
Terminated: 2024-04-05
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/25/2018, the firm sent an "Urgent Medical Device Correction" Notification Letter to Customers via FedEx (to OUS customers - emailed and hand-delivered) are asked to take actions during draping to avoid snagging the drape during installation and to continue following the instructions in the System User Manual. Representatives will be available by phone to answer questions related to the device correction. Acknowledgement form included with the recall letter is requested to be completed and returned to ISI asking that appropriate personnel be informed about the device correction.
Quantity in commerce: 1818 pouches
Distribution: Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea
Product codes and lots: Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1906-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1906-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-06

Product code NAY

K173906Class IIda Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. / cleared 2018-05-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)