Needle Driver — Class II medical device recall Z-2753-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-09-16, distributed nationwide. In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instr
| Recall number | Z-2753-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-08-08 |
| Classified | 2015-09-10 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2015-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CL, CN, CY, DE, DK, ES, FR, GB, GR, IL, IT, KR, NL, PA, RO, SA, SE, SG, TR, TW |
| Quantity | 89 units |
| Model numbers | 428056-12, 428056-13 |
Product
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. 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 and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Reason for recall
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
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-2753-2015. 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.