Intact Disposable Wands — Class II medical device recall Z-1134-2017
Terminated recall by Medtronic Advanced Energy, LLC, reported 2017-02-08, distributed nationwide. Product sterility compromised due to breach of sterile barrier
| Recall number | Z-1134-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Advanced Energy, LLC, Portsmouth, NH, United States |
| Recall initiated | 2016-12-28 |
| Classified | 2017-02-02 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CN, EG, GR, NL, TR |
| Quantity | 326 units |
| Reason classes | sterility |
Product
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Reason for recall
Product sterility compromised due to breach of sterile barrier
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-1134-2017. 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.