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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90119

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 30, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Devicor Medical Products Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

Z-1124-2022
Recall number
Z-1124-2022
Initiated
March 30, 2022
Classification
Class II
Status
Terminated
Quantity
90 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI-DI: 00841911102472 Lot F12201281D

Distribution pattern

US Nationwide distribution in the states of DE, KY, NY, OH, WV.