Tip Cover for 8mm Monopolar Curved Scissors — Class II medical device recall Z-2339-2012
Terminated recall by Intuitive Surgical, Inc., reported 2012-09-19, distributed nationwide. There is potential for the sterility of the product to be compromised.
| Recall number | Z-2339-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2012-08-09 |
| Classified | 2012-09-10 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2012-12-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, LB |
| Quantity | 11,121 boxes |
| Reason classes | sterility |
| Lot numbers | M10111028, M10111201, M10111208, M10111214, M10120130, M10120207, M10120208, M10120312, M10120315, M10120317, M10120321, M10120329, M10120413, M10120419, M10120426, M10120430, M10120507, M10120510, M10120516, M10120601 |
| Model numbers | 12000, 400180-12, IS1200 |
Product
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO).
Reason for recall
There is potential for the sterility of the product to be compromised.
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-2339-2012. 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.