CLASS II Device recall · Reported 9 Mar 2016 · FDA Enforcement Report

Kopans Breast Lesion Localization Needle The Kopans Breast recalled

Cook is recalling Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle, distributed nationwide in the US. The recall was initiated on 8 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

Quantity recalled134

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1028-2016
FDA event ID: 73083
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2016
FDA classified: 29 Feb 2016
Reported: 9 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Syringes & Needles

Timeline

8 Jan 2016	Recall initiated by company
29 Feb 2016	Classified by FDA	+52 days
9 Mar 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..

Nationwide Arizona California Georgia Illinois Missouri Mississippi Montana North Carolina New Hampshire New York Ohio Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

Where was it sold?

Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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