Bard DuaLok Breast Lesion Localization Wire — Class II medical device recall Z-2648-2014
Terminated recall by Bard Peripheral Vascular Inc, reported 2014-09-24, distributed nationwide. Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of havi
| Recall number | Z-2648-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2014-08-26 |
| Classified | 2014-09-16 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 177,760 units |
| Reason classes | sterility |
Product
Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.
Reason for recall
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a 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-2648-2014. 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.