FDA Device recall Z-1425-2013
Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar C…
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar C… by Intuitive Surgical, citing clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1425-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-23 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
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
Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
Identifiers
| code_info | Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1425-2013%22
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