Bard DuaLok Breast Lesion Localization Wire
Medical device recall Z-2648-2014. Published in FDA’s Enforcement Report on Sep 24, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 24, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 177,760 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
177,760 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
LW0037 REVH0625 LW0037 REVJ0285 LW0037 REVK0279 LW0037 REWD1346 LW0037 REWE1663 LW0037 REWH0210 LW0037 REWJ1662 LW0037 REWL1233 LW0037 REXC0151 LW0037 REXC1597 LW0037 REXJ0487 LW0037 REXK2010 LW0037 REYB1500 LW0037 REYC1644 LW0037 REYE2175…
Every code shown here, 2,000 characters
LW0037 REVH0625 LW0037 REVJ0285 LW0037 REVK0279 LW0037 REWD1346 LW0037 REWE1663 LW0037 REWH0210 LW0037 REWJ1662 LW0037 REWL1233 LW0037 REXC0151 LW0037 REXC1597 LW0037 REXJ0487 LW0037 REXK2010 LW0037 REYB1500 LW0037 REYC1644 LW0037 REYE2175 LW0037 REYG0975 LW0057 REVH1110 LW0057 REXF0126 LW0057 REVJ0284 LW0057 REXF2249 LW0057 REVJ1392 LW0057 REXG2346 LW0057 REVK0821 LW0057 REXH0014 LW0057 REWA0386 LW0057 REXH1180 LW0057 REWB0291 LW0057 REXJ0280 LW0057 REWB1686 LW0057 REXJ0560 LW0057 REWC0831 LW0057 REXJ2036 LW0057 REWD1328 LW0057 REXK0397 LW0057 REWE1476 LW0057 REXK0676 LW0057 REWF1566 LW0057 REXL0506 LW0057 REWG1788 LW0057 REYA0345 LW0057 REWG1807 LW0057 REYA1244 LW0057 REWJ1663 LW0057 REYA2521 LW0057 REWJ1664 LW0057 REYB1364 LW0057 REWK1459 LW0057 REYC0520 LW0057 REWL1432 LW0057 REYD1314 LW0057 REXB0180 LW0057 REYE2170 LW0057 REXC0152 LW0057 REYF0719 LW0057 REXC1592 LW0057 REYF1846 LW0077 REVJ0287 LW0077 REWI1706 LW0077 REXH1476 LW0077 REVJ1391 LW0077 REWJ1174 LW0077 REXH1519 LW0077 REVK0280 LW0077 REWJ1679 LW0077 REXI1623 LW0077 REVL0641 LW0077 REWK1425 LW0077 REXI1846 LW0077 REWA1600 LW0077 REWL0885 LW0077 REXJ2030 LW0077 REWB0099 LW0077 REWL1436 LW0077 REXK0937 LW0077 REWB1751 LW0077 REXA1813 LW0077 REYA0199 LW0077 REWC0848 LW0077 REXC0751 LW0077 REYA0346 LW0077 REWC1485 LW0077 REXC1113 LW0077 REYA2522 LW0077 REWD1230 LW0077 REXD1361 LW0077 REYB1366 LW0077 REWD1426 LW0077 REXD1362 LW0077 REYC0486 LW0077 REWE1052 LW0077 REXE1361 LW0077 REYC0648 LW0077 REWE1479 LW0077 REXF0129 LW0077 REYC2209 LW0077 REWF0904 LW0077 REXG0098 LW0077 REYD1387 LW0077 REWG1776 LW0077 REXG0602 LW0077 REYE2137 LW0077 REWH0282 LW0077 REXG1586 LW0077 REYF1017 LW0077 REWI0065 LW0077 REXG2360 LW0077 REYG1057 LW0107 REVH1111 LW0107 REWI1586 LW0107 REXJ0484 LW0107 REVJ0282 LW0107 REWI1746 LW0107 REXJ1985 LW0107 REVK0267 LW0107 REWJ1560 LW0107 REXJ2326 LW0107 REVK0284 LW0107 REWK0101 LW0107 REXK1320 LW0107 REVK0817 LW0107 REWK1426 LW0107 REXK2000 LW0107 REVL0570 LW0107 REWL1438 LW0107 REXL0556…
FDA’s list runs to 3,311 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 26, 2014.
- FDA classified it on Sep 16, 2014.
- FDA’s Enforcement Report published it on Sep 24, 2014.
- FDA terminated it on Mar 6, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bard Peripheral Vascular Inc, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,311 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.