| Date Initiated by Firm | April 24, 2026 |
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| Date Posted | May 27, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2239-2026 |
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| Recall Event ID |
98843 |
| 510(K)Number | K212158 |
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| Product Classification |
Marker, radiographic, implantable - Product Code NEU
|
| Product | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 |
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| Code Information |
Lot Number: F12607207D |
| FEI Number |
3008492462
|
Recalling Firm/
Manufacturer |
Devicor Medical Products Inc
300 E Business Way Fl 5
Cincinnati OH 45241-2384
|
| For Additional Information Contact | Jack Cummings
1-513-2051196 |
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Manufacturer Reason
for Recall | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
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FDA Determined
Cause 2 | Labeling mix-ups |
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| Action | An URGENT FIELD SAFETY RECALL was sent to customers beginning 4/24/26.
Action to be taken by the user:
As a result of this notification, please conduct the following:
"Examine your inventory and identify any devices from Lot F12607207D.
"Immediately remove from use any devices labeled as 4010 02 15 T4 from this lot.
"Contact your local sales representative to coordinate next steps. The affected product (devices labeled as4010 02 15 T4 from lot F12607207D) may either:
-Be handed to a sales representative for removal, or
-Be disposed of at your facility in accordance with local and institutional disposal requirements.
"If a marker from this lot has already been implanted, review and update patient records as appropriate.
"Complete and return the Recall Response Form (included with this notification), even if you no longer have affected product, to confirm the receipt of this notice and completion of required actions.
If you have any additional questions, comments or concerns please contact our Customer Support at +1 877-926-2666. You may also email Vivian.boyd@mammotome.com. |
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| Quantity in Commerce | 1910 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Singapore. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = NEU
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