da Vinci Xi and X 12-8 mm Conductive Cannula Reducer — Class II medical device recall Z-0702-2022
Ongoing recall by Intuitive Surgical, Inc., reported 2022-03-09, distributed nationwide. Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surger
| Recall number | Z-0702-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2021-12-23 |
| Classified | 2022-03-01 |
| Reported by FDA | 2022-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, KR, LU, MX, NL, NO, PL, QA, RO, SA, SE, SG, SK, TR, TW |
| Quantity | 149,646 reducers |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00886874112588 |
| Model numbers | 470381-11 |
Product
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Reason for recall
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
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.