Recall Z-2239-2026 ยท NEU Marker, Radiographic, Implantable
Devicor Medical Products Inc
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
| Date | May 27, 2026 (initiated Apr 24, 2026) |
| Status | Open, Classified |
| Reason | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| Root cause | Labeling mix-ups |
| 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 institutiona |
| Quantity | 1910 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212158 | HydroMARK Breast Biopsy Site Marker Devicor Medical Products, Inc., Apr 21, 2022 |