Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2239-2026
• FDA 510(k) clearance · K212158The device's official FDA premarket clearance record
• FDA device classification · NEUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Devicor Medical Products IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.