FDA Medical devices recall ·
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 recall
- Recall number
- Z-2239-2026
- Date
- (initiated April 24, 2026)
- Company / brand
- Devicor Medical Products Inc
300 E Business Way Fl 5, Cincinnati, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1910 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Why was it recalled?
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Number: F12607207D
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2239-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.