Kopans Breast Lesion Localization Needle The Kopans Breast Lesion… — Class II medical device recall Z-1028-2016
Terminated recall by Cook Inc., reported 2016-03-09, distributed nationwide. Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a res
| Recall number | Z-1028-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2016-01-08 |
| Classified | 2016-02-29 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 134 |
| Reason classes | microbial contamination, foreign material |
| Lot numbers | 6215428 |
| Model numbers | DKBL-20-7.0-A |
Product
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.
Reason for recall
Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.
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-1028-2016. 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.