HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

FDA device recall Z-2239-2026 · posted 2026-05-27 · Open, Classified

Recall details

Recalling firm

Devicor Medical Products Inc

Reason for recall

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

Action taken

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.

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

NEU

Quantity affected

1910 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore.

Date initiated

2026-04-24

Date posted

2026-05-27

Location

Cincinnati, OH

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