8 mm Monopolar Curved Scissors — Class II medical device recall Z-1442-2013
Terminated recall by Intuitive Surgical, Inc., reported 2013-06-12, distributed nationwide. Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 1
| Recall number | Z-1442-2013 |
|---|---|
| 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 | 2013-05-31 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IT, JP, KR, KW, LB, MX, MY, NL, NO, NZ, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, TR, TW, VE |
| Quantity | 132,441 instruments |
| Reason classes | packaging |
| Model numbers | 400179-09, 420179-09 |
Product
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
Reason for recall
Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
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-1442-2013. 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.