BioZorb F0405Recalls & reported problems
Hologic, Inc. · BioZorb Marker · Class 2 · Implant
All models of BioZorb (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045514065), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 injury.
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Oct 10, 2024Open, Classified
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Z-0328-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 13, 2024Open, Classified
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
Z-1733-2024 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Breast Discomfort/Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 69 YEARS OLD FEMALE PATIENT RECEIVED A BIOZORB IMPLANT IN (B)(6) 2022 AND REMOVED ON (B)(6) 2024 ON HER RIGHT BREAST. PATIENT COMPLAINED OF PAIN AT THE SITE OF IMPLANTATION, THE MARKER WAS REMOVED AND THE SURGEON REPORTED FOUND THE MARKER IN PIECES. PATIENT REPORTED THAT PRIOR TO REMOVAL OF DEVICE THERE WAS A PERSISTENCE OF LUMP, PINCHING AND SHARP PAINS, TENDER TO TOUCH, FELT THAT SHIFTED AND HAD CHANGED SHAPE. IT WAS REPORTED THAT THE STRUCTURE HAD COLLAPSED AND LAYING FLAT COMPRESSED AND SIDEWAYS, REMOVAL REQUIRED EXTENSIVE EXPLORATION OF THE CAVITY. AN IMAGE OF THE DEVICE EXPLANTED WAS PROVIDED IN WHICH SEVERAL PIECES WERE OBSERVED. NO OTHER INFORMATION AVAILABLE.
Patient problems: Breast Discomfort/Pain
MAUDE report 20077999 ↗
Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices
- BioZorb F0202Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls192 reports
- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- BioZorb F0203Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0303Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0404Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page