# FDA recall Z-1733-2024

> **Hologic, Inc** · Class I · device recall initiated 2024-03-13.

## Product

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

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1733-2024
- **Recalling firm:** Hologic, Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-13
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1733-2024

## Citation

> AI Analytics. FDA recall Z-1733-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1733-2024. Source: US FDA. Licensed CC0.

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