Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1124-2022 — HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

U.S. FDA — Device Enforcement · United States · 2022-03-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1124-2022
Date of alert
2022-03-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Devicor Medical Products Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00841911102472
Reported risk: Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.