8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci… — Class II medical device recall Z-1433-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-06-05, distributed nationwide. Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cab
| Recall number | Z-1433-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2013-05-08 |
| Classified | 2013-05-29 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FR, GB, IT, NL, NO, QA, RO, SA, SE, SG, TW, VE |
| Quantity | 697 |
| Lot numbers | M10120816, M10120820, M10120903, M10120910, M10120912, M10120921, M10121008, M10121024, M10121120, M10121130, M10121206, M10121213, M10121215, M10130124, M10130131, M10130213, M10130218, M10130222, M10130313, M10130319, M10130402 |
| Model numbers | 400205-04, IS1200 |
Product
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Reason for recall
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Machine access
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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.