Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 9, 2016
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.
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.…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cook Inc. recalled Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle co… - a moderate-severity action.
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle co… was recalled by Cook Inc. in March 9, 2016. Reason: Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a r…. Check the official notice for the remedy. Verify recall #Z-1028-2016 with the FDA Devices before acting.
The recall
Cook Inc. issued this moderate-severity FDA Devices recall-Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a r….
- Moderate
- severity level
- 134 units
- affected scope
- Class II
- classification
- March 9, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1028-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1028-2016) was formally reported on March 9, 2016, with the manufacturer initiating the action on January 8, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 134.
The documented reason for this recall is: 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 bl… Distribution data in the federal record shows the product reached: Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA... Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
134
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1028-2016 |
| Date reported | March 9, 2016 |
| Date initiated | January 8, 2016 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 134 |
| Distribution | Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA.. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1028-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 134.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2016. Severity: Moderate. Recall number: Z-1028-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA...
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1028-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 9, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.