Recall archive / FDA device enforcement
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm — FDA record Z-0406-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
- Reason
- There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
- Classification
- Class II
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 317 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0406-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 6, 2023
- Recall initiation date
- Oct 6, 2023
- Center classification date
- Nov 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.