Single Site Curved Needed Driver Intuitive Surgical — Class II medical device recall Z-0111-2014
Terminated recall by Intuitive Surgical, Inc., reported 2013-11-06, distributed nationwide. A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle D
| Recall number | Z-0111-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-10-02 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, FR, GB, IT |
| Lot numbers | S10130314, S10130319, S10130327, S10130401, S10130405, S10130406, S10130411, S10130412, S10130502, S10130521, S10130613, S10130626, S10130703, S10130709 |
| Model numbers | 428088-12 |
Product
Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 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, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Reason for recall
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0111-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.