FDA Devices recall · Reported May 15, 2024
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complicatio…
Hologic, Inc recalled BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites… - a critical-severity action.
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites… was recalled by Hologic, Inc in May 15, 2024. Reason: Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, devi…. Check the official notice for the remedy. Verify recall #Z-1733-2024 with the FDA Devices before acting.
The recall
Hologic, Inc issued this critical-severity FDA Devices recall-Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, devi….
- Critical
- severity level
- 53K units
- affected scope
- Class I
- classification
- May 15, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1733-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
Reason for recall
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1733-2024 |
| Date reported | May 15, 2024 |
| Date initiated | March 13, 2024 |
| Recalling firm | Hologic, Inc |
| Firm location | Marlborough, MA |
| Affected scope | 53492 |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1733-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026