Tip Cover Accessory — Class II medical device recall Z-1425-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-06-05, distributed nationwide. Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical S
| Recall number | Z-1425-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2011-09-23 |
| Classified | 2013-05-29 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IN, IT, JP, KR, MX, MY, NL, NO, NZ, PH, PK, PL, PT, QA, RO, RU, SA, SE, SI, TH, TR, TW |
| Reason classes | labeling |
| Model numbers | 400180-10 |
Product
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
Reason for recall
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
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-1425-2013. 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.