Notice names this product. Devicor Medical Products’s HydroMARK Breast Biopsy Site Marker is named in FDA Class II recall Z-2239-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. Identifying details: Lot Number: F12607207D. Units affected: 1910 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Company / brand: Devicor Medical Products recalls
Affected product: HydroMARK Breast Biopsy Site Marker recall status
Official ID Z-2239-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.