Z-0328-2025Class I

BioZorb Marker. Radiographic soft tissue marker

Name: Z-0328-2025 BioZorb Marker. Radiographic soft tissue marker
Creator: Hologic, Inc
Published: 2024-10-10
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2024-10-10 / Open, Classified / root cause: design

FDA source

Hologic, Inc began a recall of BioZorb Marker. Radiographic soft tissue marker on 2024-10-10. FDA classified it as Class I and gives the reason as "Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0328-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-10
Posted: 2024-11-26
Recalling firm: Hologic, Inc.
Product: BioZorb Marker. Radiographic soft tissue marker.
Product code: NEU Marker, Radiographic, Implantable
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.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent an URGENT: MEDICAL DEVICE RECALL letter by mail dated 10/24/24. The notification instructs consignees to quarantine all affected devices and share the recall notification with all surgeons in their practice that have used or planned to use the BioZorb Marker. Additionally, if product was further distributed the notice is to be forwarded to those customers. Affected devices will be returned to Hologic and coordination of return will be initiated by return of the Customer Response Form. Healthcare providers are recommended to be aware of reports of serious adverse events following the placement of the BioZorb Marker devices in breast tissue and to continue to monitor patients for signs of any adverse events. BioZorb Markers are not cleared to fill space in the tissue or improve cosmetic outcomes after procedures. Patients are recommended to contact their healthcare provider if they experience any adverse events following the placement of their BioZorb marker. Hologic states that there is no need to undergo explantation of the device unless advised by your healthcare provider. Patients who have received the BioZorb Marker and/or your provider is planning radiation therapy treatments, discuss the possible risks with your provider. Report any problems/complications and direct any questions regarding this recall to Hologic at [email protected]. ***Update May 5, 2026: On April 6, 2026 A Follow-up notification as an updated resource for clinicians who have previously used Biozorb breast markers or are currently caring for patients implanted with BioZorb markers. Hologic recalled and removed from market BioZorb and BioZorb LP on October 24, 2024; therefore, all patients with these implants have had them in place for at least one year. The original notification that was distributed as a part of the previous recall can be found as an appendix to this resource.
Quantity in commerce: 12,710 units
Distribution: Domestic: US Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0328-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0328-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-26

Product code NEU

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)