Z-0406-2024Class II

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Name: Z-0406-2024 Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Creator: Intuitive Surgical, Inc.
Published: 2023-10-06
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2023-10-06 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm on 2023-10-06. FDA classified it as Class II and gives the reason as "There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0406-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-06
Posted: 2023-11-28
Recalling firm: Intuitive Surgical, Inc.
Product: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 24, 2023, Intuitive issued a "Urgent Medical Device Recall notification" to all affected consignees via E.Mail. Intuitive asked consignees to take the following actions: 1. Read and understand the contents of the letter. 2. Locate and return all affected lots of 478115-03 in your inventory via the standard RMA process by calling Intuitive Customer Service based on your region below. 3. Notify all surgeons, personnel, and sites using da Vinci X and da Vinci Xi Single Site Wristed Needle Driver, PN 478115-03 that they should review and understand the contents of this letter. 4. Complete the attached Acknowledgement Form immediately and return it via email to Intuitive as instructed on the form. a. Please retain a copy of this letter and the acknowledgement form for your files. 5. Inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject device via the standard complaint process. 6. For Customers in the US: 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. a. Complete and submit the report Online Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. 8. Inform all affected personnel at your site who use da Vinci procedures when the return has been completed.
Quantity in commerce: 317 units
Distribution: US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
Product codes and lots: UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0406-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0406-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-28

Product code NAY

K152448Class IIda Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc. / cleared 2016-03-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)