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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 3, 2026

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Verification delayed

The last verified facts remain visible. Last successful verification: Jul 31, 2026, 12:43 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Identifiers to compare

  • Model 4010-02-15-T3
  • Lot F12607207D
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3Lot Number: F12607207D1910 unitsZ-2239-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Worldwide distribution - US Nationwide and the countries of Canada, Singapore.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.