Devicor Medical Products Inc: Marker, Radiographic, Implantable
Devicor Medical Products is recalling HydroMARK Breast Biopsy Site Markers (Model 4010-02-15-T3) because some boxes contain individual packages labeled incorrectly as T4 Markers instead of T3. The markers were distributed nationwide across the US as well as in Canada and Singapore. This is a Class II recall, meaning there is a potential for serious adverse health consequences.
- Recalling firm
- Devicor Medical Products Inc
- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Reason
- Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1307004e-8534-4baa-955f-e77b5a2a4c3b