da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No — Class II medical device recall Z-3025-2018
Ongoing recall by Intuitive Surgical, Inc., reported 2018-09-19, distributed nationwide. Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of t
| Recall number | Z-3025-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2018-08-15 |
| Classified | 2018-09-12 |
| Reported by FDA | 2018-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, MX, NL, NO, PK, QA, RO, SA, SE, SG, SK, TH, TR, TW, VE, ZA |
| Quantity | 42,274 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00886874112298 |
| Lot numbers | N10160301, N10160316, N10160329, N10160331, N10160404, N10160405, N10160412, N10160414, N10160418, N10160419, N10160426, N10160427, N10160428, N10160504, N10160505, N10160506, N10160511, N10160512, N10160513, N10160516, N10160517, N10160519, N10160520, N10160524, N10160525, N10160526, N10160527, N10160601, N10160606, N10160607, N10160608, N10160610, N10160613, N10160615, N10160617, N10160620, N10160624, N10160628, N10160701, N10160706 and 330 more |
| Model numbers | 470179-14, 47179-14 |
Product
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: 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. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Reason for recall
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
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-3025-2018. 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.