FDA alerts to Class I recall of BioZorb Marker by Hologic, Inc. due to major risks posed by implanted devices

On May 22, 2024, the FDA released a communication warning consumers that Hologic, Inc.’s recall of its BioZorb Marker has been identified as Class I, the most serious type, because use of the product may lead to major injuries or death.

Initiated by Hologic, Inc., formerly Focal Therapeutics, on March 13, 2024, the corrective recall covers 53, 492 devices that were distributed across the U.S. between April 29, 2019 and April 1, 2024. Nine different model numbers of the BioZorb Marker are impacted:

  • F0405 BioZorb Marker 4cm x 5cm
  • F0404 BioZorb Marker 4cm x 4cm
  • F0331 BioZorb Marker 1cm x 3cm x 3cm
  • F0231 BioZorb Marker 1cm x 3cm x 2cm
  • F0221 BioZorb Marker 1cm x 3cm x 2cm
  • F0304 BioZorb Marker 3cm x 4cm
  • F0303 BioZorb Marker 3cm x 3cm
  • F0203 BioZorb Marker 2cm x 3cm
  • F0202 BioZorb Marker 2cm x 2cm

A radiographic marker that is implanted to mark soft tissue (as in breast tissue) in anticipation of medical procedures like radiation, the Biozorb Marker comes sterile and is meant for a single use. It’s composed of two parts: a permanent, titanium metal component, as well as a component made of plastic material that is designed to completely dissolve and be absorbed by the body over time.

Company officials took action after being alerted to reports of complications and adverse incidents associated with the devices after implantation: “pain, infection, rash, device migration, device erosion, seroma, discomfort,” as well as complications related to sensation of the device in the breast, and other events requiring additional medical intervention for product removal.

To date of the May 22, 2024, FDA communication, Hologic, Inc. has received a total of 71 reported injuries. No deaths have been reported.

Those likely to be affected by the recall are as follows:

  • patients who received a BioZarb marker implant
  • patients who receive BioZarb marker-guided radiation treatment which may have resulted in a migration
  • people who undergo systemic cancer treatments may experience delays related to BioZorb Marker complications
  • certain healthcare providers such as radiologists, surgeons, and oncologists who administer the BioZorb Marker during treatment

A letter labeled as an “Important Medical Device Safety Notification” was sent to all Hologic, Inc. customers on March 13, 2024, with the following requests of both patients and healthcare providers:


  • Following the placement of a BioZorb Marker, healthcare providers should be alerted to any experience of adverse events.
  • When considering breast cancer procedures, all the benefits and possible risks of implantable breast tissue markers should be discussed with a healthcare provider.
  • Any complications that arise following the placement of BioZorb Marker devices should be reported to Hologic via email at breasthealth.support@hologic.com, as well as to the FDA’s MedWatch Adverse Event Reporting program.

Healthcare Providers:

  • Maintain awareness of major adverse events that may arise following an implantation of a BioZorb Marker device in breast tissue.
  • Ensure that each patient is aware of the benefits and potential risks associated with BioZorb Marker devices.
  • In the event that a marking device will be used during breast conservation surgery, ensure that all patients are informed about which will be used.
  • Following an implantation of a BioZorb Marker, be sure to continually monitor patients for any indication of adverse events.
  • Following placement of a device, be sure that any complications experienced by a patient is reported to Hologic via the email provided above, as well as to the FDA’s MedWatch Adverse Event Reporting program.


Our compassionate attorneys at TruLaw work tirelessly to safeguard consumer safety standards and hold negligent parties responsible for pain and suffering. If you or someone you love has experienced an adverse health outcome due to complications from an implanted device, we would like to help you pursue justice and maximum compensation. Contact us today or take our free Instant Case Evaluation ℠ to get started.