Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S — Class II medical device recall Z-1226-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-03-11. There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer po
| Recall number | Z-1226-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-02-16 |
| Classified | 2015-02-27 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-07-01 |
| Countries outside the US | BE, BR, CA, CH, CN, ES, FI, FR, GB, GR, IN, IT, JP, KR, QA, RU, SA, TR, TW |
| Quantity | 706 units |
| Reason classes | sterility |
| Model numbers | 420187-05 |
Product
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
Reason for recall
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
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-1226-2015. 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.