5X250 MM Curved Cannula — Class II medical device recall Z-1334-2014
Terminated recall by Intuitive Surgical, Inc., reported 2014-04-16. Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae t
| Recall number | Z-1334-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-03-13 |
| Classified | 2014-04-04 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-09-03 |
| Countries outside the US | AU, BE, BR, CH, CL, CN, DE, DK, ES, FR, GB, IN, IT, KR, LB, NL, NO, RO, SA, SE, TR |
| Quantity | 5,217 cannulae |
| Reason classes | labeling |
| Lot numbers | VE113001, VE113401, VE114001, VE114401, VE120602, VE120701, VE121004, VE121007, VE121103, VE121105, VE121109, VE121110, VE121205, VE121407, VE121410, VE121604, VE121608, VE121804, VE122004, VE122005, VE122104, VE122204, VE122302, VE122403, VE122604, VE122901, VE122904, VE122908, VE122911, VE123007, VE123014, VE123107, VE123202 |
| Model numbers | 428071-03, IS3000 |
Product
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road 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, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
Reason for recall
Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
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-1334-2014. 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.