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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95639

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

Open FDA event record

Event summary

Timeline bucket
October 10, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Hologic, 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

BioZorb Marker. Radiographic soft tissue marker.

Z-0328-2025
Recall number
Z-0328-2025
Initiated
October 10, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Hologic, Inc
Quantity
12,710 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

Code information

Model No. F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202; UDI-DI: 15420045514065, 15420045514058, 15420045514041, 15420045514034, 15420045514027, 15420045514010, 15420045514003, 15420045513990, 15420045513983; Lot No. 22E24RH, 23A09RK, 23L23RP, 22E24RG, 23A09RJ, 23E03R, 23G28RW, 22F06RL, 22G26RQ, 22K25RA, 23A09RH, 23A30RP, 23C02RJ, 23H25RW, 23K04RC, 23K31RG, 24A30RG, 22D21RBB, 22F06RK, 22F29RK, 22G26RP, 22H24RM, 22J26RG, 22K25R, 22L22R, 22M20RM, 23A26RV, 23C02RH, 23E27RF, 23F29RT, 23H03R, 23H25RU, 23K04RA, 23L23RK, 24B02RD, 24B27RK, 22D21RAA, 22E24RA, 22F29RJ, 22G26RN, 22H24RL, 22J26RF, 22K21R, 22L22RA, 22M20RL, 23A26RU, 23C02RG, 23C30RQ, 23E03RA, 23F29RP, 23G28RV, 23H25RV, 23K02RB, 23K31RD, 23L23RH, 24A08RY, 24B01R, 24B27RL, 24C22RN, 22D21RZ, 22E24RB, 22F25RF, 22G26RM, 22H24RK, 22J26RD, 22K19RW, 22L22RB, 23C02RK, 23E25RY, 23F29RS, 23H24RP, 23K04RB, 23K31RF, 23L23RJ, 22D21RY, 22E24R, 22F25RD, 22G26RL, 22H22RT, 22J26RC, 22K19RV, 22L22RC, 23A09RN, 23H03RA, 23H31R, 23K04RD, 23K25RM, 22D21RX, 22E20RAA, 22F21R, 22G21RM, 22H22RS, 22J22RBB, 22K19RU, 22L22RF, 23A09RM, 23A30RQ, 23B24RZ, 23C30RP, 23D27RJ, 23E31RD, 23F28RZ, 23G31RJ, 23H24RQ, 23K02RA, 23K25RN, 22D20RV, 22E20RZ, 22F16RV, 22G21RL, 22H20R, 22J22RAA, 22K19RT, 22K25RB, 22L22RD, 23A09RL, 23B24RY, 23C28RJ, 23D27RH, 23E30RF, 23F29RQ, 23G31RH, 23H24RN, 23K02R, 23K25RL.

Distribution pattern

Domestic: US Nationwide Distribution.