Large Needle Driver — Class II medical device recall Z-0521-2014
Terminated recall by Intuitive Surgical, Inc., reported 2013-12-25, distributed nationwide. Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Need
| Recall number | Z-0521-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-11-15 |
| Classified | 2013-12-16 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, FI, FR, GB, IE, KR, NL, NO, SE, SK |
| Reason classes | device malfunction |
| Lot numbers | 1110072, 1610072, 1710072, 610072, 710182, 710192, 710222, 710242, 710262, 710301, 710302, 711052, 711062, 711072, 711082, 711092, 711122, 711128, 711132, 711142, 711152, 711262, 711272, 711282, 711302, 712042, 712062, 712102, 712112, 712122, 712142, 712182, 712192, 712212, 712262, 712272, 801021, 801022, 801072, 801092 and 460 more |
| Model numbers | 400006, 420006 |
Product
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Reason for recall
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
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-0521-2014. 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.